Associate Director, Quality Assurance
Merck
June 24, 2026
Remote
United States
Operations
Position Overview
Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance provides independent compliance support for Medical Devices (including the device constituent part of Combination Products). Ensures compliance with 21CFR 820, 21CFR Part 4 (Combination Products), ISO 14971 device risk management, and other worldwide regulations.
Primary Activities
- Represent DQ&R Quality on commercial and product/core development teams; address quality issues.
- Review/approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance; evaluate deficiencies and compliance impact.
- Develop/revise DQ&R Quality policies and procedures.
- Guide Manufacturing and R&D device functions to implement end-to-end Design Control.
- Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products.
- Participate in all stages of combo product development, including purchasing controls and supplier quality oversight.
- Work with external partners.
- Review/approve verification/validation protocols and reports.
- Provide input to design/manufacturing documentation (material specs, drawings, inspection and manufacturing procedures).
- Translate customer needs into critical-to-quality design inputs/outputs.
- Lead and manage development of Design & Development File deliverables for medical devices.
Skills/Qualifications
- 7+ years relevant experience; Bachelor’s (Science/Engineering) + 7 years OR Master’s + 5 OR PhD + 3.
- Extensive knowledge: 21CFR820, 21CFR Part 4, EU MDR, ISO 13485.
- Experience: Design Controls/CAPA/Purchasing Controls (21CFR820); Risk Management (ISO 14971/24971, ICH Q9).
- Strong technical writing/review; independent work in cross-functional matrix; effective written/oral communication.
Preferred
- Remediation; current GMPs for combination products; Lean Six Sigma/ASQ certifications; GMP/QDP and project management; Lean Six Sigma tools (DOE, RCA/problem-solving) and statistical techniques.
Location/Travel/Work
- US-based (NJ/PA or other US location); Travel <10%; Remote.
Application
- Apply via https://jobs.merck.com/us/en. Job posting end date: 07/10/2026; apply by 11:59:59PM the day before.
Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance provides independent compliance support for Medical Devices (including the device constituent part of Combination Products). Ensures compliance with 21CFR 820, 21CFR Part 4 (Combination Products), ISO 14971 device risk management, and other worldwide regulations.
Primary Activities
- Represent DQ&R Quality on commercial and product/core development teams; address quality issues.
- Review/approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance; evaluate deficiencies and compliance impact.
- Develop/revise DQ&R Quality policies and procedures.
- Guide Manufacturing and R&D device functions to implement end-to-end Design Control.
- Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products.
- Participate in all stages of combo product development, including purchasing controls and supplier quality oversight.
- Work with external partners.
- Review/approve verification/validation protocols and reports.
- Provide input to design/manufacturing documentation (material specs, drawings, inspection and manufacturing procedures).
- Translate customer needs into critical-to-quality design inputs/outputs.
- Lead and manage development of Design & Development File deliverables for medical devices.
Skills/Qualifications
- 7+ years relevant experience; Bachelor’s (Science/Engineering) + 7 years OR Master’s + 5 OR PhD + 3.
- Extensive knowledge: 21CFR820, 21CFR Part 4, EU MDR, ISO 13485.
- Experience: Design Controls/CAPA/Purchasing Controls (21CFR820); Risk Management (ISO 14971/24971, ICH Q9).
- Strong technical writing/review; independent work in cross-functional matrix; effective written/oral communication.
Preferred
- Remediation; current GMPs for combination products; Lean Six Sigma/ASQ certifications; GMP/QDP and project management; Lean Six Sigma tools (DOE, RCA/problem-solving) and statistical techniques.
Location/Travel/Work
- US-based (NJ/PA or other US location); Travel <10%; Remote.
Application
- Apply via https://jobs.merck.com/us/en. Job posting end date: 07/10/2026; apply by 11:59:59PM the day before.