Associate Director, Quality Assurance
About The Position
The Associate Director, Quality Engineering & Quality Assurance reports to the Senior Director of Device Quality and Regulatory (DQ&R) and provides independent compliance support and leadership for medical devices, including the device constituent parts of combination products. The role works across functions and employee levels to develop, document, and maintain technical business solutions and to review and approve documentation supporting regulatory filings. It also audits data, policies, procedures, and systems for compliance with medical device and combination product regulations, including 21 CFR 820, 21 CFR Part 4, ISO 14971, and other worldwide regulations and company requirements. The position supports quality oversight for prospective medical devices and combination products throughout development, manufacturing, and post-market activities. It is US-based and remote, with travel of less than 10% of the time. The primary posting location is Rahway, New Jersey.
Requirements
- Bachelor’s degree in science, engineering, or an associated field and at least 7 years of related experience; or a master’s degree in those fields and at least 5 years of related experience; or a Ph.D. in those fields and at least 3 years of related experience.
- Extensive knowledge of applicable medical device regulations, including 21 CFR 820, 21 CFR Part 4, EU MDR, and ISO 13485.
- Experience with Design Controls, CAPA, and Purchasing Controls as related to 21 CFR 820.
- Risk Management experience, including ISO 14971/24971 and ICH Q9.
- 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.
- Creative thinking, resourcefulness, and networking skills to coordinate projects and solve problems.
- Ability to work in a matrix organization with effective written and oral communication.
- Travel of less than 10% of the time.
Nice To Haves
- Remediation experience.
- Knowledge of current GMPs for combination products.
- Certified Lean Six Sigma Green Belt or Black Belt, or ASQ certification.
- Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP), and project management principles.
- Knowledge of Lean Six Sigma principles and tools, such as DOEs, root cause analysis, and problem-solving methods.
- Experience using root cause analysis and applied statistical techniques.
Responsibilities
- Represent the DQ&R Quality function on commercial and product/core development teams, supporting quality issues related to medical devices and device constituents of combination products.
- Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-market surveillance; evaluate deficiencies and assess their compliance impact.
- Contribute to the development and revision of DQ&R Quality policies and procedures and those of supported areas.
- Stay informed about worldwide regulations and industry standards and trends.
- Guide Manufacturing and Research and Development device functions and other personnel in effective implementation of end-to-end Design Control principles.
- 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 and validation test protocols and reports to ensure testing meets 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 manufactured and tested adequately.
- Translate customer needs into critical-to-quality and design input/output requirements, including chemical, physical, and performance specifications.
- Lead and manage development of Design and Development File deliverables for medical devices.
Benefits
- Medical insurance
- Dental insurance
- Vision healthcare benefits
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Senior
