Senior Engineer, Advanced Quality

Stryker

Portage, MI, US
Base: $77,700 - $129,500 usd annual; bonus/equity:...
Hybrid
Bachelor's degree in engineering or science
2+ years experience in regulated environment
Experience applying capa and audit processes
This role leads quality engineering activities within new product development projects for medical devices

Job Summary

  • This role leads quality engineering activities within new product development projects for medical devices.
  • Candidates must reside within commuting distance of Portage, MI and work onsite several days per week.
  • The position involves developing verification strategies and analyzing quality data to resolve issues.

Matching Summary

This role leads quality engineering activities within new product development projects for medical devices.

Salary

Base: $77,700 - $129,500 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or Science
  • 2+ years experience in regulated environment
  • Experience applying CAPA and audit processes
  • Support design control and risk management
  • Statistical analysis for acceptance criteria

Nice-to-have

  • Certified Quality Engineer (CQE) certification
  • Six Sigma Green or Black Belt
  • Advanced quality tools like FMEA
  • Root cause analysis and mistake-proofing
  • Experience with FDA and TUV interactions

Key Requirements

  • Minimum 2 years experience in regulated environment
  • Bachelor's degree in Engineering, Science, or related discipline
  • Experience interacting with regulatory agencies like FDA

Work Rights

Not specified

Tailored Resume

Cover Letter