Associate Director, Medical Device Quality & Compliance

Merck; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Paid holidays and vacation

Job summary

Merck is seeking an Associate Director of Quality Engineering & Quality Assurance to provide independent compliance support for medical devices and device components of combination products. The role collaborates with cross-functional teams, reviews regulatory documentation, and guides design control, CAPA, and risk management to ensure regulatory and company standards.

You will contribute to policy development, stay current with global regulations, and support end-to-end quality oversight

Qualifications

• Bachelor’s degree in Science or Engineering with related experience or higher degrees with fewer years of experience.
• Experience with medical device regulations and quality systems.

Responsibilities

• Act as DQ&R Quality function representative on cross-functional teams.
• Review and approve design control and device risk management docs for regulatory filings.
• Develop/update policies and procedures for DQ&R Quality.
• Provide guidance to Manufacturing and R&D device functions for end-to-end design control.
• Lead design reviews, CAPA reviews, and ad-hoc technical reviews of combo products.

Skills

Clinical Quality Assurance

Combination Products

CSV

Design Thinking

Detail-Oriented

GMP Compliance

GCP

GMP

Interpersonal Relationships

Project Management

Lean Six Sigma

Manufacturing Audits

Quality Assurance (QA)

Quality Control Management

Quality Improvement Programs

Medical Device Regulations

Education

Bachelor’s degree in Science or Engineering or associated fields

Master’s degree in Science or Engineering or associated fields

Ph.D. in Science or Engineering or associated fields

Tools

None specified

Job description

Merck is seeking an Associate Director of Quality Engineering & Quality Assurance to provide independent compliance support for medical devices and device components of combination products. The role collaborates with cross-functional teams, reviews regulatory documentation, and guides design control, CAPA, and risk management to ensure regulatory and company standards.

You will contribute to policy development, stay current with global regulations, and support end-to-end quality oversight