Senior Manager, Design Quality

Intelex

Remote
Base: $133,600.00 - $248,500.00; bonus/equity: not...
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Iso 14971 risk management expertise
Iec 62366 usability engineering standards
Fda 21 cfr part 820 qmsr knowledge
** Intelex is seeking a Senior Manager of Design Quality to ensure high-quality, compliant product launches in the medical device sector. This remote role involves overseeing design quality standards, risk management, and cross-functional collaboration, while leading a team of design quality engineers. **

Job Summary

  • The Senior Manager, Design Quality is accountable for the execution and governance of design quality across the entire product lifecycle from user needs to post-market performance.
  • This role requires deep expertise in regulatory standards including ISO 13485, ISO 14971, and FDA regulations to ensure products are safe, effective, and inspection-ready.
  • The position involves leading a team of design quality engineers while partnering with R&D, Clinical, and Regulatory functions to drive continuous product improvement.

Matching Summary

Match Score: 75

** Intelex is seeking a Senior Manager of Design Quality to ensure high-quality, compliant product launches in the medical device sector. This remote role involves overseeing design quality standards, risk management, and cross-functional collaboration, while leading a team of design quality engineers. **

Salary

Base: $133,600.00 - $248,500.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • ISO 14971 risk management expertise
  • IEC 62366 usability engineering standards
  • FDA 21 CFR Part 820 QMSR knowledge
  • Design History File (DHF) oversight
  • Verification and Validation strategy approval
  • Team leadership of quality engineers

Nice-to-have

  • Fortive Business System experience
  • Post-market surveillance insights application
  • Cross-functional collaboration skills
  • Continuous improvement culture promotion
  • Statistical analysis for quality sampling

Key Requirements

  • Bachelor's degree in Engineering or Science
  • 12+ years in medical device quality/engineering
  • 7+ years managing people and managers
  • Experience preparing for FDA and Notified Body inspections

Work Rights

Not specified

Tailored Resume

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