Quality Manager Jobs in Maple Shade, NJ

Are you a quality-focused leader passionate about improving product performance and ensuring exceptional customer satisfaction? We're seeking a Sr. Manager of Quality Engineering to lead initiatives that enhance product quality, resolve customer issues, and elevate operational standards. This role is based on the East Coast and will require relocation. Key Responsibilities As a Sr. Manager, you will oversee post-market quality operations, including: Leading product quality evaluations and root cause investigations based on customer feedback and field reports. Developing and monitoring performance metrics to ensure alignment with quality standards and identifying areas for improvement. Building and managing a customer-facing quality team to collaborate with sales and service teams, participate in field visits, and address quality escalations. Driving swift resolution of product quality issues, including recalls, adverse event reporting, and effective communication with regulatory bodies. Collaborating with cross-functional teams such as R&D, Manufacturing, and Supplier Quality to implement quality improvements and expedite solutions. Conducting health risk assessments for complaints, CAPAs, and field actions while ensuring compliance with industry regulations. Analyzing investigation findings and presenting actionable trends and recommendations to leadership. Providing input to new product development teams to ensure quality considerations are built into product design. Qualifications and Expertise Required Experience: 7+ years in a regulated industry (medical device preferred), with proven management experience. Education: Bachelor's degree in an engineering or scientific discipline (e.g., Mechanical, Electrical, or equivalent). Knowledge: Familiarity with regulatory standards such as 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, and Canadian MDR. Expertise in complaint processing, CAPA management, and statistical analysis. Experience in facilitating cross-functional collaboration and managing post-market quality data. Leadership: Skilled in developing and managing high-performing teams, with a strong focus on engagement and professional development.

Job Title: Director of Quality Assurance Industry: Personal Care Packaging We are seeking an experienced Director of Quality Assurance to lead and oversee our Quality Department at our Burlington, NJ facility. The ideal candidate will have extensive experience in FDA, DEA, ISO, GMP regulatory compliance and a proven track record in quality management within the personal care packaging industry. This individual will be responsible for maintaining and enhancing our quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives. Key Responsibilities: Lead the Quality Assurance (QA) department, ensuring compliance with FDA, DEA, ISO, and GMP regulations. Oversee and manage all quality-related processes, including non-conformance, deviations, and other quality events. Develop, implement, and maintain CAPA (Corrective and Preventive Action) programs to address quality issues. Conduct Root Cause Analysis (RCA) for customer complaints and internal non-conformances to drive quality improvements. Ensure compliance with regulatory submission requirements, including NDA (New Drug Application) and BLA (Biologics License Application) presentations. Collaborate with cross-functional teams to develop and implement quality initiatives and ensure product integrity. Monitor and improve Quality Management Systems (QMS) to enhance efficiency and effectiveness. Establish and maintain quality policies, procedures, and standard operating procedures (SOPs). Lead internal and external audits, ensuring compliance with industry standards and regulatory requirements. Provide training and development programs for the QA team to enhance technical competencies. Ensure effective handling of customer complaints, deviations, and investigations to improve customer satisfaction. Stay updated on industry trends, regulatory changes, and best practices to maintain compliance and continuous improvement. Qualifications: Bachelor's degree in a relevant scientific or engineering discipline. Minimum of 7-10 years of experience in Quality Assurance within the personal care, pharmaceutical, or related industries. Proven experience managing a Quality Department and leading a team. Strong knowledge of FDA, DEA, ISO, and GMP regulations and compliance requirements. Experience with NDA and BLA regulatory submissions is a plus. Expertise in Root Cause Analysis, CAPA, non-conformance, and deviation management. Excellent leadership, communication, and problem-solving skills. Ability to manage multiple projects and prioritize tasks in a fast-paced environment. Experience leading regulatory inspections and audits. Strong analytical skills with a data-driven approach to decision-making. Compensation & Benefits: Competitive salary commensurate with experience. Comprehensive benefits package including health, dental, and vision coverage. 401(k) plan with company matching. Paid time off and holiday benefits. Professional development and training opportunities. If you are a highly motivated Quality Assurance professional with leadership experience and a passion for compliance and continuous improvement, we encourage you to apply for this exciting opportunity.

Over a decade of expertise in software quality assurance, including more than five years in leadership positions. Demonstrated proficiency in test automation, with practical experience using tools such as Selenium, NUnit, and MSTest. Skills and Competencies: In-depth understanding of the Software Development Life Cycle (SDLC) and agile methodologies. Proven leadership and team management abilities. Strong analytical and problem-solving capabilities. Outstanding communication and interpersonal skills. Adept at thriving in fast-paced settings and handling multiple projects concurrently. Technical Proficiencies: Expertise in the .NET framework and C# programming. Skilled in utilizing Azure DevOps Experience with Continuous Integration/Continuous Deployment (CI/CD) tools and methodologies. Knowledgeable in performance testing tools and techniques.

🚀 We're Hiring: Quality Assurance Manager Are you looking to take the next step in your Quality Assurance career? This is an exciting opportunity to play a key role in a growing organization, ensuring compliance with U.S. GMP/GDP regulations while driving quality improvements across operations. 📌 The Role As a Quality Assurance Manager, you will be responsible for maintaining and enhancing QA processes to meet industry standards and regulatory requirements. You'll oversee compliance with U.S. GMP/GDP regulations, support audits and inspections, and contribute to the continuous improvement of quality systems. Additionally, you'll have the opportunity to mentor and guide team members, helping to foster a strong quality culture. 🌟 What makes this special? ✅ Take ownership of key quality processes and initiatives. ✅ Contribute to a dynamic, fast-paced environment with room for growth. ✅ Work in a company that values innovation, collaboration, and continuous improvement. ✅ Enjoy a supportive culture that promotes work-life balance. 🎯 What We're Looking For ✔ Experience in Quality Assurance within GMP/GDP-regulated environments. ✔ Strong knowledge of U.S. regulations and quality standards. ✔ Ability to support audits, inspections, and compliance initiatives. ✔ Problem-solving skills with a keen eye for process improvements. ✔ A proactive and collaborative mindset, ready to drive quality excellence.

Job Title: IT Quality Assurance Manager Schedule: Monday-Friday 8:00am - 5:00pm Location: Willingboro, New Jersey (required full time on site) Radwell International is seeking a highly skilled and motivated IT Quality Assurance (QA) Manager to lead our QA team in ensuring the quality, reliability, and performance of our IT systems, software, and applications. The IT QA Manager will oversee all aspects of quality assurance, focusing on manual testing, test planning, strategy, and team leadership. This role requires strong technical expertise, excellent leadership skills, and a deep understanding of QA methodologies to support the successful delivery of high-quality IT solutions. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Develop and implement comprehensive QA strategies for software, systems, and applications across the organization. Collaborate with stakeholders (developers, product managers, business analysts) to define test requirements, test plans, and acceptance criteria. Ensure the development of detailed test documentation, including test cases, test scripts, and test data. Lead, mentor, and manage a team of QA engineers, fostering a collaborative and results-driven environment. Provide coaching, career development, and performance management for team members. Set clear objectives for the QA team, ensuring alignment with organizational goals. Oversee manual testing efforts to ensure the quality and reliability of software and systems. Track and report on testing progress, including identifying issues and ensuring timely resolution. Monitor the execution of test cases, defects, and system performance to ensure high standards are met. Conduct root cause analysis for defects and work with development teams to identify improvements in the testing process. Continuously evaluate and improve QA processes and methodologies to increase efficiency, accuracy, and quality of testing efforts. Ensure adherence to best practices and quality standards for software development and testing (e.g., Agile, Scrum) Stay current with industry trends, tools, and technologies to enhance the QA team's capabilities. Work closely with developers, product managers, and business analysts to ensure the proper integration of QA activities into the software development lifecycle (SDLC). Act as the main point of contact for quality assurance-related matters within cross-functional teams. Facilitate communication between different teams to ensure the smooth execution of testing plans. Define and track key performance indicators (KPIs) for the QA process, including test coverage, defect rates, and overall software quality. Provide regular reporting on testing progress, defect status, and overall quality metrics to senior leadership. May be modified from time to time. Other duties may be assigned. METRICS To consistently meet monthly deadlines and objectives as agreed and typically described in monthly reviews or through other project planning efforts To handle ongoing projects and day-to-day demands that are not identified in formal monthly objectives in a timely and accurate manner Adherence to budgets Adherence to/achievement of benefits described in project business case (cost/benefit) analyses QUALIFICATIONS Strong knowledge of IT program management methodologies (e.g., Agile, Scrum, Waterfall) and software development life cycles (SDLC). Excellent leadership, communication, and interpersonal skills. Proven ability to manage multiple projects simultaneously and prioritize tasks effectively. Strong problem-solving skills and the ability to navigate complex situations. Familiarity with project management software (e.g., Jira, Microsoft Project, etc.). Epicor Prophet 21 knowledge is a plus. KNOWLEDGE & SKILLS REQUIRED Ability to make and keep commitments to the team Ability to solve complex problems Ability to quickly learn and apply new technical skills in both a classroom and independent study setting Attention to detail Ability to work effectively with little or no supervision Strong written and verbal communication skills Goal oriented program management skills EDUCATION & EXPERIENCE Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field. 5+ years of experience in software quality assurance, with at least 2 years in a managerial or leadership role. CERTIFICATES, LICENSES, REGISTRATIONS PMP (Project Management Professional) or similar certification is a plus. PHYSICAL DEMANDS Continuous sitting and typing for extended periods. Occasional, reaching/working overhead, climbing or balancing, stooping, kneeling, crouching or crawling Lifting requirements include occasional lifting of up to 25 pounds WORK SCHEDULE This is an exempt position which requires a work schedule that will achieve the results and objectives identified by the company and the VP of IT. Generally the company operates and most of those who will interface with this position work normal business hours which are 8:00am to 5:00pm Monday through Friday. Nights and weekends may be worked at the VP of IT's discretion based on current project and implementation needs, deadlines, and workload.

Manager, Quality Control (QC) Microbiology - Permanent - Philadelphia, PA Proclinical is seeking a dedicated Quality Control Manager to oversee the daily operations of cGMP QC testing for drug products, focusing on lot release and stability. Primary Responsibilities: This role involves managing microbial testing, environmental monitoring, and supporting product stability programs. The successful candidate will also be responsible for authoring and reviewing quality control documents and leading investigations for out-of-specification results. Skills & Requirements: Bachelor's degree in biological sciences or equivalent. Broad knowledge of biological drug development and quality control. Strong analytical, written, and verbal communication skills. Ability to manage multiple priorities and work under tight deadlines. Problem-solving skills with a proactive approach to challenges. Experience with cell therapy products is a plus. Ability to wear clean room attire and PPE, and perform physical tasks such as lifting up to 45 pounds. Comfortable working in both office and lab settings with potential exposure to chemicals and biohazards. The Manager, Quality Control Microbiology's responsibilities will be: Oversee analysts in day-to-day QC testing and manage microbial testing at contract labs. Handle technical transfer, qualification, and validation of microbiology test methods. Manage the facility's environmental monitoring program. Author, review, and approve SOPs, protocols, reports, and specifications. Conduct trend analysis and generate reports for environmental monitoring data. Lead investigations for out-of-specification results and corrective actions. Support product stability programs and contamination control efforts. Maintain a microbial identification database for in-house isolates. Participate in site qualification, validation, and commissioning activities. Serve as a qualified trainer and support team career development. Establish positive relationships with internal and external partners. Solve technical issues related to GMP quality control efficiently. If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonaldo at a.maldonaldo@proclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Quality Program Manager Duration: 6 Months Job Type: Contract Work Type: Onsite Pay rate: $40/hr. to $45/hr. ON W2 TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client produces electronics and HVAC equipment. The Company offers HVAC equipment, building automation, security, fire detection, batteries, and other related products, as well as building control systems, energy management, and integrated facility management services. Client serves customers worldwide. Job Description: The Quality Program Manager is the individual retained by the O&M Contractor with the authority and responsibility for quality management, quality system-related activities for all O&M Contractor Work, including the maintenance of, and compliance with the QMP. The Quality Program Manager shall be independent from staff and duties associated with the production of the O&M Contractor Work. The Quality Program Manager shall have undertaken training in the use and application of Quality Programs including the application of International Organization for Standardization [ISO] 9001:2015 and possess a CMQ/OE certification. Additionally I would like the individual to have a Safety Background as the Quality Role will be bifurcated and have a 25% safety contingent. TekWissen Group is an equal opportunity employer supporting workforce diversity.

The Quality Control Manager is responsible for overseeing and managing the quality control processes related to primary packaging materials and finished products. This role ensures that packaging materials meet quality standards, regulatory requirements, and company specifications. Responsibilities: Develop, implement, and maintain quality control procedures and standards for primary packaging materials Conduct regular inspections and testing of packaging materials to ensure compliance with specifications and regulatory requirements Identify and address any quality issues, including investigating root causes and implementing corrective actions Maintain accurate and detailed records of quality control inspections, test results, and compliance reports Prepare and present quality reports and metrics to management, highlighting key issues, trends, and improvements Ensure all documentation is up-to-date and in compliance with company policies and regulatory standards Provide training and guidance to production staff on quality standards, procedures, and best practices Ensure that all packaging materials and processes comply with relevant regulations, standards, and company policies Requirements: Bachelor's Degree in Quality Assurance, Chemistry, Packaging Engineering, or similar field 5+ years of experience in QC or QA; 2+ years of supervisory experience Strong knowledge of primary packaging materials, testing methods, and regulatory requirements Proficiency in quality management systems and software

A Quality Control Technician is an advanced technical role requiring a thorough understanding of optical parameters. The ideal candidate will serve as a subject matter expert in optical performance verification, train others on test equipment, and interpret spectral specifications on drawings to create robust inspection documents. Additionally, they will be responsible for reviewing inspection reports from other team members and, at times, support the lab to ensure proper allocation of resources and timely completion of tasks. The Technician must be well-versed in QA Lab equipment, including its applications for measuring specific products and parameters. With job-specific training, they will perform their duties in compliance with authorized EO inspection procedures and contribute to developing these procedures. Responsibilities: Perform precise measurements to verify optical profiles using industry standard techniques and equipment, such as spherometers, profilometers, Vision Measuring Machines (VMM), Coordinate Measuring Machines (CMM), and interferometers. Verify coating performance using appropriate methods and tools, including UV/Vis/NIR/FIR spectrophotometers with URA, 3D modules, and GPOB accessories. Provide support as the acting lead for QC personnel when the Supervisor is unavailable. Train inspectors and technicians on proper: Operation of lab and inspection equipment. Inspection and measurement techniques. Optical drawing interpretation. First Article Inspection (FAI) document review and process. Support the development and revision of work instructions for inspection and measurement activities. Perform cosmetic inspections for both optical and non-optical components. Conduct dimensional and optical measurements to ensure compliance with specifications. Review and approve inspection methods and reports as necessary. Serve as a technical liaison with other departments as needed. Ensure compliance with federal, state, and company policies, procedures, and regulations. Qualifications The ideal candidate will have prior supervisory experience. To succeed in this role, candidates must be able to perform all essential functions effectively. The requirements listed below reflect the necessary knowledge, skills, and abilities. Reasonable accommodations may be provided to individuals with disabilities to help them perform essential functions. Requirements: Proficient in reading and interpreting optical and mechanical drawings; experience with balloon drawing software is preferred. Skilled in operating precision measurement tools, with some expertise in measuring optical components. Previous experience with SAP or similar ERP system. Previous experience in ISO-compliant environments, with knowledge of standards and documentation (ISO 9001, ISO 13485, or AS9100 preferred). Strong commitment to maintaining accurate and honest Quality Records in compliance with industry standards. Fundamental understanding of manufacturing processes, workflows, and standard operating procedures. US Citizenship or permanent residency required. Education/Experience: Bachelor's degree in Engineering, Physics, or a related science preferred but not required. Candidates with relevant experience in an engineering/manufacturing environment or an ASQ certification may be considered. Physical Requirements: Ability to lift up to 50 pounds; ability to see details at a close range; ability to sit or stand for long periods of time. Adequate eyesight to perform the job accurately. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Think you meet some of the requirements but not all? Studies have shown that women and people of color are less likely to apply to jobs for which they do not meet every qualification. If you see a role that interests you, we encourage you to apply, regardless of whether or not your experience is completely aligned with the job description. Edmund Optics is committed to becoming the most diverse, equitable, and inclusive workplace within the Optics and Photonics Industry and beyond. You may be a great candidate for this role or others within Edmund Optics.

At Universal Pure, we're dedicated to giving people everywhere safe, fresh, and delicious food to eat and drink. We provide high-pressure processing (HPP), value-added services and cold storage for our partners in the food industry. We are focused on safety and driven by service. Quality Assurance Supervisor Position Summary: The Quality Assurance Supervisor is the food safety coordinator and quality advocate for the assigned facility. Key drivers are supporting the quality control function within the company while ensuring policies like Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOP) are executed. The position requires knowledge of quality methods, techniques, and equipment. The QA Supervisor must have or achieve within a reasonable timeframe certification in SQF, HACCP, and PCQI. The role reports to the Regional Quality Assurance Manager. This position has 4-5 direct reports that compromise hourly 3-4 QA Techs and 1 Sanitation rep. Typical Hours between 7:00am- 5:00pm Mon-Fri, with flexibility to work weekends. Supervisors must also cover shifts when team members are out. Quality Assurance Supervisor Essential Duties and Responsibilities: Assists the Quality Regional Manager in developing and maintaining Standard Operating Procedures and company programs. Provide leadership on quality and food safety programs. Ensure product is processed to company HACCP/HARPC programs. Responsible for informing Quality Assurance Management of ANY Food Safety. Ability to implement and manage food safety corrective actions. Oversee the development, implementation, review, and maintenance of the SQF System Ensure training of facility personnel on GMPs, pre-requisite programs, and other applicable food safety system elements as required. Maintain document registers and documentation. Aid in hosting visitors or function as the main contact to the facility during regulatory agency audits, customer audits, and third-party audits. Site SQF Practitioner. Quality Assurance Supervisor REQUIRED Job Qualifications: 2+ years supervisory experience in quality assurance Minimum 5 years QA experience, preferably in the food manufacturing industry Leadership/Management/Supervisory experience Good computer skills including Word and Excel. Experience with Access desired Extreme detail orientation and thoroughness Must be flexible with work schedule to meet the needs of operations Must have excellent interpersonal skill with internal and external customers Leadership - the ability to command and maintain attention of those you are overseeing Effective communication - the ability to convincingly convey instructions, directions, and details to others Experience - knowledge of OSHA and other governmental regulations; incident and accident prevention Attention to detail - the ability to manage all duties, rules, documentation, and other components of the job with focus and accuracy Confidentiality - the ability to protect data, information, and employee privacy Compassion - the ability to be concerned for another person's well being Organization - an ability to manage multiple priorities simultaneously Collaborative - an ability to work with diverse personalities for a tangible and beneficial outcome Quality Assurance Supervisor PREFERED Job Qualifications: Bachelor's Degree Prior manufacturing experience, preferably food manufacturing Quality Assurance Certification in SQF, HACCP, and PCQI Quality Assurance Supervisor Work Environment: This position will be performed both within our office environment and our production floor which is a wet/cold environment. At Universal Pure we offer medical, dental, vision, life insurance, and other health benefits. We also offer a 401(k) with a company match, paid vacation, paid holidays, and an attendance bonus. We are developing an effective, caring, and respectful team both in the HR department and across the organization and seek to add new employees who feel the same. "We are an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, age, national origin or disability."

- Open to relocation No Third Party Inquiries Please Open to relocation Most urgent role is for night shift - Shift: Monday to Friday from 11:00pm to 7:30am Must be eligible to work in the US. Client does not allow Visas. Key experience: Microbiological and Environmental testing experience. Must have clean room experience and comfortable being suited for clean rooms (bioburden, endotoxin, gram stain) Cell therapy a must. Overview The Manager, Quality Control (QC) Microbiology, is responsible for oversight of day-to-day microbial QC operations at Cell Therapy Center (iCTC). The role will be responsible for working in a GMP- regulated environment and have good understanding of QC microbiology test methods and environmental monitoring. This role must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to: lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. Shift: Monday to Friday from 11:00pm to 7:30am Essential Functions and Responsibilities Manage several analysts at the iCTC in the day-to-day cGMP QC testing of drug products for lot release and stability; Manage microbial testing at contract laboratories Manage the technical transfer, qualification, and validation of microbiology test methods for in- process materials, lot release, and/or stability, as needed Manage the environmental monitoring program for the facility Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents. Ensure trend analysis and trend reports for environmental monitoring data are performed timely. Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness. Support product stability programs including generation of stability protocols, execution of stability testing, stability data analysis, and final reporting of stability data. Support of site contamination control programs. Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs. Ensure trend analysis and trend reports for environmental monitoring data are performed timely. Support site qualification/validation/commissioning activities, as needed. Serve as a qualified trainer, as needed. Support career development of microbiology team members. Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment All duties are performed with minimal supervision and oversight Required Education, Skills, and Knowledge Bachelor's degree in a relevant discipline (biological sciences or equivalent) Minimum (8) years of experience in the biopharmaceutical industry within a Quality Control role Experience managing a team a plus Broad knowledge of biological drug development with respect to Quality Control Demonstrated ability to manage external partners with respect to quality control activities Successfully interface with multi-disciplined teams in a global setting Extremely detail-oriented with strong analytical, written, and verbal communication skills Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity Demonstrate sense of urgency; ability to recognize time sensitivity Flexible and adaptable style with an eagerness to take on challenges Problem solver who not only identifies issues but leads efforts to resolve them Preferred Education, Skills, and Knowledge Experience with cell therapy products The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Physical Demands and Activities Required: Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps. Must be able to use near vision to view samples at close range Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline Work Environment: This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors. The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards. LHH Recruitment Solutions has Quality Control Manager opening for our client in the Conshohocken, PA area. This direct hire role allows you to collaborate with numerous departments to facilitate quality control and process improvement as well as strategic sourcing. This on-site position requires a bachelor's degree in Biological Science or similar, and 5+ years in a medical device manufacturing Quality Control Manager role. Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards. Salary range: $80,000 to $90,000 RESPONSIBILITIES: Oversee the planning, directing, and/or coordinating quality programs, quality control, within laboratory and production efforts in a manufacturing environment. Maintain a constant working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations and industry standards Create, revise and implement procedures/controlled documents according to FDA, AATB, and other applicable regulations as needed. Manage and oversee inspection of HCT/Ps and medical devices. Define, sort, and document acceptable and unacceptable HCT/P products and/or medical devices. Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures Analyze test results and testing procedures to provide feedback and interpretation to management. Create, implement and present reports regarding any issues of products or processes, daily production quality, quality trends. Directly manage investigations of incidents related to quality to solve root cause. Manage customer complaints, investigations, and review. Provide technical expertise as needed - SME status. Create and review case studies or regulatory standards and trends to stay abreast of issues in the field of quality control and quality assurance. Identify critical points in the manufacturing process and specify sampling procedures to be used at these points. Design, implement and train and update standard operating procedures or quality assurance manuals. Verify raw materials. parts, in-process samples and finished products meet established testing and inspection standards. Instruct contractors on quality guidelines, testing policy and procedure, or ways to eliminate deficiencies. Define, order, and coordinate the selection and implementation of quality control equipment. Monitor the development of any and all new products to identify possible problems prior to mass production. Train others in quality control and communicate quality control information to all departments, vendors, or contractors. REQUIREMENTS: Bachelor's degree in a relevant Biological Sciences or Similar and/or 5+ years manufacturing experience in medical device industry. Proven experience in FDA, AATB and other applicable regulations and standards. Proven ability to oversee multiple priorities and make sound business decisions. Knowledge of the practical application of engineering science and technology - applying principles, techniques, procedures, and equipment to design and production. Knowledge of principles and methods for training, teaching and instruction for individuals and groups. QMS systems experience. Ideal candidates will have extensive experience in FDA, AATB and other applicable regulations and standards.

IntePros is looking for an Associate Quality Specialist to join one of our premier Medical Device/Manufacturing clients in Northeast Philadelphia, PA. As an Associate Quality Specialist, you will assist with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide a competitive advantage in long-term quality customer management. Associate Quality Account Manager Responsibilities: Creates, updates and peer reviews Master Packaging Instructions, forms and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Packaging Instructions and specifications. Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements. Assist with creating batch records to support the production schedule. Primary Quality Assurance contact for assigned customer accounts Assist as company liaison with customers concerning quality control documentation. Help identify, communicate, track and resolve document related issues with other departments and customers. Attend or facilitate conference calls and customer meetings to provide or obtain quality related information and customer specific metrics Assist with populating quality related metrics and key performance indicators for team's performance. Assist with initiating and investigating quality deviations with the responsible functional area. Initiating and completing supplier non-conformance reports and effectuates material control. Assist with training, developing, and mentoring new Quality Coordinators. Adherence to client and cGMP policies, procedures, rules and regulations. Quality Account Specialist Qualifications: Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. Experience with change controls, CAPAs, deviations, investigations, batch records, customer support and technical writing. Preferred experience working with cross functional teams (operations, engineering). Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Ability to identify and resolve problems in a timely manner. Ability to display a willingness to make decisions. Ability to display excellent time management skills.

A growing ophthalmic medical device company is seeking a quality assurance leader to join their organization in a crucial position. This role is vital for ensuring the highest standards of quality and regulatory compliance within the company. Role and Responsibilities Oversee the company's quality system to ensure compliance with FDA, ISO, CE, and Health Canada certification regulations, including maintaining registrations with these entities. Act as the Management Representative, keeping management updated on new regulations and the company's compliance status. Serve as the person responsible for regulatory compliance (PRRC), ensuring devices meet conformity standards, proper identification (UDI) before release, and managing post-market obligations. Handle customer complaints, including Medical Device Reporting and fulfilling Vigilance requirements. Manage activities and documentation related to Corrective/Preventive Actions. Oversee the Document Control System. Conduct internal audits and facilitate audits by external entities. Monitor environmental controls, equipment maintenance, calibration, and incoming inspection of parts and materials. Experience and Qualifications Bachelor's degree in a relevant field or equivalent work experience. At least five years of experience in a quality assurance role within the medical device environment. Two years of supervisory experience preferred. DEKRA auditing experience is preferred Skills and Knowledge In-depth understanding of ISO 13485 and FDA regulations. Strong organizational and time-management abilities. Leadership skills. Proficiency in document management software and Microsoft Office.

Perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products. Act as subject matter expert (SME) and train laboratory personnel on assays. Perform all activities with respect to GMP/GDP compliance. Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures. Support technical problem solving for issues pertaining to GMP Quality Control. Qualifications: Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience. Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control Solid understanding and functional knowledge with hands-on experience with two (2) or more of the following: Multicolor Flow Cytometry, Cell-based ELISA, cell culture with cell enumeration (NC-200) Experience in technical writing (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.) Pay Scale: $115,000 - $125,000 ( Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers' mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do. L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers' mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Job Title: Sr Specialist, Quality Engineering-Supplier Quality Job Code: 21183 Job Location: Camden, NJ Schedule: 9/80 Atl- with every other Friday off Job Description: In this role, the Supplier Quality Engineer (SQE) will support and interface across functional disciplines including Program Management, Supply Chain, Manufacturing and Engineering personnel. The SQE will be an active and significant contributor in the evaluation, development and monitoring of key Suppliers and Subcontractors, create Quality requirements, participate in the generation and review of requirements, and validate flow down of expectations. The SQE will communicate and ensure our Suppliers and Subcontractors understand stated requirements, have the capability to consistently and predictively meet, and provide conforming products and services. The SQE supports the day to day operations and is responsible for tactical issue resolution for supply chain related quality issues; both internal and at the customer. Essential Responsibilities This position will have responsibilities and perform tasks in the following areas: Implement IMS policies, procedures and standards for Supplier Management that drive a preventive, zero defect culture of quality, supplier excellence and customer satisfaction. Assess and audit new and existing supplier capabilities and ensure suppliers meet L3Harris and customer requirements. Visit suppliers to review product & process issues and perform investigation, root cause analysis, and corrective actions to drive improvements into their processes. Work proactively with L3Harris suppliers utilizing tools such as APQP and Zero-Defect Planning to mitigate the risk of escapes to L3Harris and / or L3Harris customers. Initiate and drive supplier corrective action requests (SCAR's). Train suppliers as required and ensure effective containment plans are defined and implemented, that the that root cause corrective action (RCCA) is robust and effectively implemented in the timeframe required. Analyze in-house and supplier performance and develop improvement plans for identified problem areas to drive down cost of poor quality, supplier DPPM and other non-conformance rates. Utilize Six Sigma and Lean Concepts to drive improvements and delivery metrics both internally and in the supply base. Review flow down of Program Quality requirements and ensure that they are included in the requirement documents to suppliers. Review and disposition First Article Inspection Reports (FAIRs) and ensure that product meets factory, customer and program requirements. Support the internal MRB process when supplied material is identified as nonconforming and take appropriate corrective action(s) with the supplier. Collaborate with supply chain to maintain the approved supplier list Perform other Quality Engineering tasks as assigned to support Maritime Power, Philadelphia. Qualifications: Bachelor's Degree and minimum 6 years of prior relevant experience. Graduate Degree and a minimum of 4 years of prior related experience. Experience in operations, supply chain and/or quality. AS9100/ISO9001 or equivalent quality management system and process audit experience required Able to travel up to 30% Must be a US Citizen Preferred Additional Skills: FAI, AS9102 experience Lean Manufacturing Six Sigma and/or RedX Certified APQP, SPC, FMEA, Control Plan, Measurement System Analysis (MSA) and PPAP experience Proven problem-solving experience Exceptional interpersonal and communication skills, both written and verbal. #LI-JV1 L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law. Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions. L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.

About Taylor Fresh Foods, Inc. Taylor Fresh Foods, Inc. is dedicated to being North America's favorite maker of salads and healthy fresh foods. Our “Taylor Family” includes over 20,000 team members who are passionate about making high quality, great tasting products for families across North America. As we continue to rapidly grow, we have a career opportunity available for a talented and motivated individual to join our Taylor Farms New Jersey team as Quality Improvement Supervisor. JOB SUMMARY: The Quality Improvement Supervisor is responsible for ensuring the overall consistency and quality of manufactured items throughout the production facility. This role will be responsible for ensuring the quality of manufactured items are meeting internal/customer specifications along with customer expectations. A key piece to this role is the ability to implement programs that are executable by the production operators to ensure sustainability. The Quality Improvement Supervisor is also responsible for training and reinforcement training of associates, leads, and Quality improvement coordinators as it relates to quality. This role requires interaction with associates and management but is ultimately a floor driven position as product consistency and quality are driven at the floor level. Key deliverables include: Partner with production leads, supervisors and quality leadership to develop and foster consistency around production execution. Work with Quality and Process Improvement manager to address areas of opportunity for existing product set and around commercialization efforts for new products to be produced in a given production area. Gather ideas and opportunities from the production floor to come up with quality opportunities. Help guide production supervision with completion of priority tasks as it relates to quality. Aid in execution and awareness of all new quality processing procedures. Work with QIC's and operators on proper builds and portioning during the production run. Manage day to day of the Quality improvement coordinators. Qualifications/Skills and Abilities: Bachelor's degree in related field (industrial engineering, food marketing/production, manufacturing, food science, etc.), preferred. Minimum 3 years of experience in food manufacturing company, specifically around leafy greens. Must be a self-starter capable of independently meeting objectives and interacting with members of various teams successfully. Able to think creatively and strategically. At home in a manufacturing environment and on the production floor. Ability to elicit buy-in and cooperation from a variety of individuals as well as departments. Hands-on, flexible, and responsive to dynamic fast paced work environment. Capability of multitasking and managing several initiatives. Strong team player with a continuous improvement mindset. Bi-lingual (English/Spanish) is required.

Participate in Core Supplier Management teams for purchase orders, together with the Sourcing/Fulfilment and Engineering representatives. · Work with procurement teams to define / agree / communicate to all stakeholders a roadmap for supplier development activities, identifying the supplier quality tasks to ensure the right supply chain performance to meet business objectives. · Track and drive progress against roadmap commitments, with regular reports to stakeholders and management. · Execute activities to drive safety, quality and compliance excellence and support delivery and cost performance, within the supply base for the assigned product scope. These activities include: Supplier on-boarding and qualification: · Support Supplier selection process, in cooperation with Sourcing and Engineering teams, performing technical assessment, and evaluating supplier capacity and capability (manufacturing, design, EHS, …), · Assess suppliers QMS and manufacturing process compliance through holistic process audits, · Record action plans and manage supplier approvals in the supplier database, · Lead and execute first piece qualification programs with suppliers in cooperation with other functions and subject matter experts including but not limited to: during fabrication audits, special processes audit, design reviews, functional tests (if applicable) and final product release. · Record actions plans and approve qualification requests in the supplier database. Supplier assessment and development: · Attend pre-award meetings with suppliers and Sourcing/Engineering, · Contribute to the Supplier Performance Rating process (Score Cards), · Review and update suppliers' qualification status based on their performance assessment, · Initiate and manage supplier development actions and Q improvement plans. Purchase Order Kick-off Meetings, Supplier Requirements and Design Reviews: · Ensure readiness for kick-off meeting with dedicated checklist, · Support Engineering in execution of Supplier Requirement Reviews and Supplier Design Reviews · Where applicable, review supplier quality documentation (Inspection and Test Plans, special process and NDT procedures, …). Execution of surveillance inspections: · Set up inspection strategy (standard quality inspection plans and additional inspections, as applicable), · Schedule quality surveillance and witness inspections at suppliers, · Perform surveillance and witness inspections, · Ensure product compliance with contract requirements and applicable regulations, · Timely review, validate and distribute inspection reports. Release material for shipment: · Ensure all deviations are closed, · Where applicable, review End of Manufacturing Reports (EoMR), · Authorize shipment once all quality requirements are met. Manage technical deviations: · Continuously follow up the punch items and nonconformities resulting from the quality surveillance inspections up to their closure, · Lead RCAs and RCIs with suppliers as per business-defined impact thresholds, support supplier to create the corrective and preventative actions, monitor their implementation and perform the effectiveness check, · Analyze customer escapes and Cost of Poor Quality (CoPQ) and support vendor recovery process, · Initiate and execute Supplier Quality Improvement Programs with top offenders, and, preventatively, with other suppliers of critical MLIs. Manage holistic process audits and other supplier development activities: · Organize holistic process audits, · Monitor the closure of corrective actions based on audit findings, · Record the corresponding reports in the supplier database, · Facilitate supplier Technical Advisor site installation and/or commissioning support and the corresponding lessons-learned dissemination, · Support suppliers to executes DFMEA (where applicable) and PFMEAs. Other tasks: · Drive a strong EHS culture throughout the supply base, · Support cost-out opportunities identified by the suppliers, · Propose improvement projects to increase the effectiveness of the processes, · Stop work if quality or safety is at risk and define/assess the conditions to release work. Required Professional Characteristics and Personal Skills · Minimum bachelor's degree in Electrical or Electronic Engineering, or equivalent technical field from an accredited university or college. · Previous working experience in quality, operations/supply chain or project management, preferably in electronic industry, with proficiency to understand technical drawings, specifications, and standards. · Working knowledge of manufacturing processes involved in the production of the assigned equipment (e.g. electronic parts, PCBAs, PCBs). · Excellent written and verbal English language skills, allowing effective communication across all organizational levels, departments, and functions. · Strong safety, compliance, quality, and lean mindset, with proven use of the industrial quality toolkit for risk assessment, root cause analysis, problem solving, and manufacturing process controls. · Aptitude to create and deliver reports for review by key stakeholders. · Capacity to organize working time in global team setting and willingness to adjust it based on meetings with stakeholders in different time zones.

Avo Photonics (********************* is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and communications. We seek a diligent, dedicated, and meticulous person who will help to further our success by supporting our aerospace quality system. An ideal candidate must take ownership over and strive for continuous improvement in the procedures and documentation that encompass our aerospace products. The candidate is expected to advise program managers and engineers on best-practice quality procedures, and should feel comfortable leading large-scale change within the programs they operate in. Proactivity, high attention to detail, and the ability to cooperate professionally within different levels of the organization are essential traits for success. Responsibilities: Develop and maintain manufacturing documents (component drawings, inspection documents, work instructions, travelers, and bills of materials) such that they are compliant to aerospace quality standards Managing first article inspections, nondestructive testing, and failure analysis (PFMEA, FMA), as required Ensuring all material compliances (Reach, RoHS, Conflict Minerals) and material traceability Collect and analyze production data to audit and confirm product quality Process nonconforming product and drive root cause analysis Support material source inspections and customer audits Maintaining quality documents and records Requirements: B.S. in Engineering At least 5 years of experience with electronic and/or optical technologies, measurement systems, and inspection tools At least 5 years of experience working in Quality Experience in aerospace and support of prior missions Experience managing within AS9100 & AS9003B Quality Systems preferred Strong oral and written English communications skills ASQ Quality Engineer Certification preferred Avo Photonics offers competitive salaries and a comprehensive benefits package. Equal Opportunity Employer: Avo Photonics is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee of Avo Photonics by any method without a valid written contract in place with Avo Photonics will be deemed the sole property of Avo Photonics. No fee will be paid in the event the candidate is hired by Avo Photonics as a result of the referral or through any other means. #aerospace