Design Quality Engineer (andover, Ma)

Smith & Nephew

Andover, MA, United States
Base: $81,750.00 - $122,500.00 usd annually; bonus...
On-site
Design control compliance
Risk management (iso 14971)
Design history files (dhfs)
Smith & Nephew is seeking a Design Quality Engineer to ensure the safety and quality of their Advanced Wound Management medical devices. The role involves maintaining compliance with global quality standards and participating in design control and risk management activities

Job Summary

  • Ensuring compliance with Design Control and Design Change activities independent of NPD and sustaining teams.
  • Supporting verification and validation activities to ensure outputs meet design inputs.
  • 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.

Matching Summary

Match Score: 85

Smith & Nephew is seeking a Design Quality Engineer to ensure the safety and quality of their Advanced Wound Management medical devices. The role involves maintaining compliance with global quality standards and participating in design control and risk management activities.

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, and 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 compliance
  • Risk Management (ISO 14971)
  • Design History Files (DHFs)
  • Verification and validation support
  • Medical device quality system regulations

Nice-to-have

  • Continuous improvement of SOPs
  • Collaboration with Operations and QA
  • Knowledge of best practices

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • 2+ years of experience in a 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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