Design Quality Engineer (andover, Ma)

Smith+Nephew

Andover, MA, US
Base: $81,750.00 - $122,500.00 usd annually; bonus...
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Design control requirements iso 13485
Risk management iso 14971
Fda quality system regulation qsr
** Smith+Nephew is seeking a Design Quality Engineer in Andover, MA, to ensure the design integrity and compliance of their Advanced Wound Management medical devices. The ideal candidate will have a relevant engineering degree, experience in a regulated environment, and knowledge of quality system regulations. **

Job Summary

  • This role plays a key part in ensuring new and existing products comply with global quality system regulations throughout the product lifecycle.
  • The position involves reviewing and approving Design History Files, supporting verification and validation activities, and maintaining Risk Management Files in accordance with ISO 14971.
  • Smith+Nephew offers competitive benefits including medical, dental, vision coverage, 401k matching, tuition reimbursement, and generous paid time off.

Matching Summary

Match Score: 75

** Smith+Nephew is seeking a Design Quality Engineer in Andover, MA, to ensure the design integrity and compliance of their Advanced Wound Management medical devices. The ideal candidate will have a relevant engineering degree, experience in a regulated environment, and knowledge of quality system regulations. **

Salary

Base: $81,750.00 - $122,500.00 USD annually; Bonus/Equity: Competitive bonus and discounted stock options available; Benefits: Medical, dental, vision, 401k, tuition reimbursement, parental leave

Skills & Requirements

Must-have

  • Design Control requirements ISO 13485
  • Risk Management ISO 14971
  • FDA Quality System Regulation QSR
  • GMP and quality system standards
  • Design History Files DHF review

Nice-to-have

  • Medical device software development ISO 62304
  • Health Hazard Evaluations experience
  • Instructions for Use IFU authoring

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • 2+ years of experience in regulated environment
  • Knowledge of FDA QSR and global quality systems

Work Rights

Not specified

Tailored Resume

Cover Letter