Onsite Associate Director, Device Quality & Compliance

MSD; Kansas; On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. is seeking an Associate Director, Device Quality Assurance to provide on-site quality oversight for device assembly and packaging operations at the Wilson, NC site.

This role interfaces with R&D DQ&R and ensures regulatory compliance across design transfers, qualification activities, and CAPA management. The candidate will lead cross-functional collaboration, promote patient safety, and drive quality improvements in a matrix organization, with focus on device quality and

Qualifications

• 5+ years of QA experience in medical device manufacturing.
• Bachelor’s degree in a relevant scientific discipline.
• Strong problem-solving and communication skills.
• Ability to partner and collaborate in a matrix organization.

Responsibilities

• Provide on-site quality oversight for medical device and combination product operations at the Wilson, NC site.
• Coordinate CAPA and deviations affecting device assembly and packaging operations.
• Support device design transfer, process changes, and risk assessments with DQ&R input.
• Represent QA for internal and external audits and ensure regulatory compliance.

Skills

Quality Assurance

Cross-functional collaboration

Problem solving

Technical communication

Regulatory compliance

Root cause analysis

GxP knowledge

Education

Bachelor’s degree in relevant scientific discipline

Job description

Merck & Co., Inc. is seeking an Associate Director, Device Quality Assurance to provide on-site quality oversight for device assembly and packaging operations at the Wilson, NC site.

This role interfaces with R&D DQ&R and ensures regulatory compliance across design transfers, qualification activities, and CAPA management. The candidate will lead cross-functional collaboration, promote patient safety, and drive quality improvements in a matrix organization, with focus on device quality and