Associate Director, Quality Assurance
Merck
June 24, 2026
Remote
United States
Operations
Responsibilities:
- Provide independent compliance support for medical devices and device constituent parts of combination products.
- Represent Device Quality & Regulatory (DQ&R) on commercial and product/core development teams.
- Review/approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance; assess deficiencies and compliance impact.
- Contribute to DQ&R Quality policy/procedure development.
- Guide Manufacturing and R&D to ensure end-to-end Design Control implementation.
- Participate in design reviews, CAPA reviews, and ad-hoc technical reviews; support all stages of combination product development (incl. purchasing controls and supplier quality).
- Work with external partners; review/approve verification/validation protocols and reports.
- Provide input to design/manufacturing documentation (materials, drawings, inspection/manufacturing procedures) and translate customer needs into CTQ requirements.
- Lead development of Design and Development File deliverables.
Primary Qualifications/Skills:
- 7+ years relevant experience.
- Extensive knowledge of 21 CFR 820, 21 CFR Part 4, EU MDR, ISO 13485.
- Experience with Design Controls/CAPA/Purchasing Controls (21 CFR 820).
- Risk Management (ISO 14971/24971, ICH Q9).
- Strong technical writing/review; independent work in a cross-functional matrix.
Preferred:
- Remediation experience; combination-product GMP knowledge.
- Lean Six Sigma (Green/Black Belt) or ASQ certification.
- Knowledge of GMP/QDP and project management; DOE/RCA/statistics.
Education:
- Bachelor’s (Science/Engineering) + 7 years; or Master’s + 5 years; or PhD + 3 years.
Location/Travel:
- US-based (NJ/PA or other US location); travel <10%.
Benefits (if applicable):
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline listed on the posting. Job posting effective until 11:59:59PM the day before end date.
- Provide independent compliance support for medical devices and device constituent parts of combination products.
- Represent Device Quality & Regulatory (DQ&R) on commercial and product/core development teams.
- Review/approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance; assess deficiencies and compliance impact.
- Contribute to DQ&R Quality policy/procedure development.
- Guide Manufacturing and R&D to ensure end-to-end Design Control implementation.
- Participate in design reviews, CAPA reviews, and ad-hoc technical reviews; support all stages of combination product development (incl. purchasing controls and supplier quality).
- Work with external partners; review/approve verification/validation protocols and reports.
- Provide input to design/manufacturing documentation (materials, drawings, inspection/manufacturing procedures) and translate customer needs into CTQ requirements.
- Lead development of Design and Development File deliverables.
Primary Qualifications/Skills:
- 7+ years relevant experience.
- Extensive knowledge of 21 CFR 820, 21 CFR Part 4, EU MDR, ISO 13485.
- Experience with Design Controls/CAPA/Purchasing Controls (21 CFR 820).
- Risk Management (ISO 14971/24971, ICH Q9).
- Strong technical writing/review; independent work in a cross-functional matrix.
Preferred:
- Remediation experience; combination-product GMP knowledge.
- Lean Six Sigma (Green/Black Belt) or ASQ certification.
- Knowledge of GMP/QDP and project management; DOE/RCA/statistics.
Education:
- Bachelor’s (Science/Engineering) + 7 years; or Master’s + 5 years; or PhD + 3 years.
Location/Travel:
- US-based (NJ/PA or other US location); travel <10%.
Benefits (if applicable):
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline listed on the posting. Job posting effective until 11:59:59PM the day before end date.