Associate Director, Quality Assurance

Position Overview Associate Director Quality Engineering & Quality Assurance Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. The role interacts with cross‑functional teams and works with all levels of employees to develop, document, and maintain technical business solutions, review and approve medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21 CFR 820s) and Combination Product current Good Manufacturing ruling (21 CFR Part4), Device Risk Management (ISO14971) and other worldwide regulations and company requirements. The associate provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products. Primary Activities Actively represent DQ&R Quality function on commercial and product/core development teams supporting quality issues related to medical devices or the device constituent of a combination product. Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post‑marketing surveillance. Evaluate deficiencies and assess impact on compliance status. Contribute to developing and revising policy and procedures for DQ&R Quality and/or supported areas. Remain informed of industry trends as described in worldwide regulations and industry standards. Provide guidance to Manufacturing and Research & Development device functions and other personnel to ensure end‑to‑end Design Control principles are implemented effectively. Participate in design reviews, CAPA reviews, and ad‑hoc technical reviews of combination products. Participate in all stages of combination product development including oversight of purchasing controls and supplier quality. Work with external partners to develop products. Review and approve verification/validation test protocols and reports to ensure testing is sufficient to meet regulatory requirements and quality objectives. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure products can be adequately manufactured and tested. Facilitate translation of customer needs into critical to quality and design input/output requirements, including chemical, physical, or performance specifications. Lead and manage development of Design and Development File deliverables for medical devices. Skills 7 years of relevant work experience. Extensive knowledge of applicable medical device regulations (21 CFR820, 21 CFR Part4, EUMDR, ISO13485). Experience with Design Controls, CAPA, and Purchasing Controls as it relates to 21CFR820. Risk Management experience (ISO14971/24971, ICHQ9). Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices. Ability to work independently within a cross‑functional framework and perform detailed technical writing and review. A high degree of creative thinking, resourcefulness, and networking to coordinate projects or solve problems. Ability to work in a matrix organization and be an effective written and oral communicator. Preferred Experience Remediation experience. Knowledge of current GMPs for combination products. Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications. Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP), and project management principles. Lean Six Sigma Principles and tools such as DOEs, root‑cause analysis, and problem‑solving methods. Experience in the use of root‑cause analysis and applied statistical techniques. Qualifications Bachelor’s degree in Science, Engineering, or associated fields with at least 7 years related experience. Master’s degree in Science, Engineering, or associated fields with at least 5 years related experience. PhD in Science, Engineering, or associated fields with at least 3 years related experience. US‑based (NJ/PA or other US location). Travel: Yes, Benefits & Compensation Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, and other insurance for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. #J-18808-Ljbffr