Design Quality Engineer (andover, Ma)

Smith & Nephew

Andover, MA, USA
Base: $81,750.00 - $122,500.00 usd annually; bonus...
Design control and design change activities
Design history files (dhfs) review
Verification and validation support
This role plays a key part in ensuring new and existing products comply with global quality system regulations and applicable standards throughout the product lifecycle

Job Summary

  • This role plays a key part in ensuring new and existing products comply with global quality system regulations and applicable standards throughout the product lifecycle.
  • In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.
  • Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Matching Summary

This role plays a key part in ensuring new and existing products comply with global quality system regulations and applicable standards throughout the product lifecycle.

Salary

Base: $81,750.00 - $122,500.00 USD annually; Bonus/Equity: competitive bonus; Benefits: medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP

Skills & Requirements

Must-have

  • Design Control and Design Change activities
  • Design History Files (DHFs) review
  • Verification and validation support
  • Risk analyses and product testing
  • Risk Management Files (ISO 14971)
  • Product lifecycle compliance

Nice-to-have

  • Medical device software development (ISO 62304)
  • Continuous improvement of SOPs
  • Maintaining current knowledge of standards

Key Requirements

  • Bachelor’s degree in engineering or life sciences
  • 2+ years of experience in regulated environment
  • Exposure to Design Control (ISO 13485)
  • Exposure to Risk Management (ISO 14971)
  • Knowledge of FDA QSR and global quality systems
  • Experience with GMP and quality system standards

Work Rights

Not specified

Tailored Resume

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