Associate Director, Device Quality Assurance - Hybrid

Merck & Co., Inc.

Wilson, North Carolina, United States
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 day remote)
5 years qa experience in medical devices
Device assembly and packaging operations knowledge
Design transfer and validation (iq/oq/pq)
Merck & Co., Inc. is seeking an Associate Director of Device Quality Assurance for their Wilson, North Carolina location, focusing on overseeing medical device quality and regulatory support for assembly and packaging operations. The role emphasizes partnership with various teams and promotes a culture of early problem identification and resolution, ensuring patient safety and product quality

Job Summary

  • This role serves as the primary interface between R&D and the Wilson, NC site for device quality and regulatory support.
  • The successful candidate will be accountable for coordinating triage, root cause investigations, and CAPA activities for device assembly operations.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director of Device Quality Assurance for their Wilson, North Carolina location, focusing on overseeing medical device quality and regulatory support for assembly and packaging operations. The role emphasizes partnership with various teams and promotes a culture of early problem identification and resolution, ensuring patient safety and product quality.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive available; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 5 years QA experience in medical devices
  • Device assembly and packaging operations knowledge
  • Design transfer and validation (IQ/OQ/PQ)
  • CAPA coordination and root cause investigation
  • GMP and regulatory compliance expertise

Nice-to-have

  • Strong cross-functional partnership skills
  • Culture of early issue surfacing
  • Experience with combination products
  • Change management adaptability
  • Global audit representation experience

Key Requirements

  • Bachelor's degree in relevant discipline
  • 5 years relevant QA experience in medical device manufacturing
  • US or Puerto Rico residency required

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

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