Associate Director, Quality Systems & Compliance (design Controls)

Merck & Co., Inc.

Base: $129,000.00 - $203,100.00; bonus/equity: ann...
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10 years experience in pharmaceutical or medical devices
Knowledge of iso 13485 and fda 21 cfr part 820
Expertise in quality management system document authoring
** Merck & Co., Inc. is seeking an Associate Director in Quality Systems & Compliance with a focus on medical device design controls. The role involves leading continuous improvement initiatives, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. **

Job Summary

  • The Associate Director will lead continuous improvement initiatives supporting the Manufacturing Division's Quality Management System Topic 3.3 Design Controls.
  • This role requires deep expertise in US FDA regulations, EU MDR, and ISO standards to ensure site compliance and manage global quality topics.
  • The position offers a competitive salary range of $129,000 to $203,100 along with comprehensive benefits including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an Associate Director in Quality Systems & Compliance with a focus on medical device design controls. The role involves leading continuous improvement initiatives, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. **

Salary

Base: $129,000.00 - $203,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 10 years experience in pharmaceutical or medical devices
  • Knowledge of ISO 13485 and FDA 21 CFR Part 820
  • Expertise in Quality Management System document authoring
  • Experience with CAPA implementation and audit resolution
  • Strong knowledge of IEC 62304 software lifecycle processes

Nice-to-have

  • Cross-cultural team collaboration skills
  • Continuous improvement initiative leadership
  • Ability to foster a culture of continuous improvement
  • Experience with global QMS topic alignment
  • Effective communication in diverse team forums

Key Requirements

  • B.S. or M.S. degree in Science or Engineering
  • Minimum 10 years of relevant industry experience
  • 3+ years specific experience in Regulatory CMC or Quality
  • Working knowledge of design controls and risk management

Work Rights

Not specified

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