Associate Director, Device Supplier Management

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Base: $129,000.00 - $203,100.00; bonus/equity: ann...
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Medical device supplier quality management
Fda 21 cfr part 820 compliance
Eu mdr 2017/745 knowledge
** The Associate Director, Device Supplier Management position at Merck involves leading initiatives related to Quality Management Systems (QMS) and supplier management for medical devices. The role requires collaboration across teams to ensure compliance with regulatory standards and improve supplier quality management processes. **

Job Summary

  • The Associate Director will lead initiatives to establish early commercialization purchasing controls and integrate device supplier management across MDCP programs.
  • This role ensures compliance with cGMPs, FDA regulations, and EU MDR while driving continuous improvement in device supplier quality management.
  • Candidates must have at least 8 years of experience in pharmaceutical or medical devices with a minimum of 4 years specifically in supplier quality management.

Matching Summary

Match Score: 75

** The Associate Director, Device Supplier Management position at Merck involves leading initiatives related to Quality Management Systems (QMS) and supplier management for medical devices. The role requires collaboration across teams to ensure compliance with regulatory standards and improve supplier quality management processes. **

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

Skills & Requirements

Must-have

  • Medical Device Supplier Quality Management
  • FDA 21 CFR Part 820 Compliance
  • EU MDR 2017/745 Knowledge
  • ISO 13485:2016 Implementation
  • Supplier Audit Execution
  • GMP Purchasing Controls
  • Quality Agreement Management

Nice-to-have

  • Cross-functional Team Collaboration
  • Strategic Planning Skills
  • Influencing Stakeholders
  • Continuous Improvement Mindset
  • Electronic System Proficiency
  • Combination Product Experience

Key Requirements

  • B.S. or M.S. in Science or Engineering
  • Minimum 8 years industry experience
  • At least 4 years in Supplier Quality Management
  • Expertise in FDA 21 CFR Part 4 and Part 820
  • Knowledge of EU MDR 2017/745 and ISO 13485
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

Cover Letter