Design Quality Engineer

Philips

Bedford, MA, United States
Base: $102,480 to $163,968; bonus/equity: annual i...
Fully remote
Design control process management
Process validation strategies
Risk management iso 14971
The Design Quality Engineer leads the entire design control process and executes comprehensive process validation strategies to ensure new products meet quality and regulatory standards

Job Summary

  • The Design Quality Engineer leads the entire design control process and executes comprehensive process validation strategies to ensure new products meet quality and regulatory standards.
  • Philips offers a comprehensive Total Rewards benefits program including generous PTO, 401k match, HSA contributions, stock purchase plan, and education reimbursement.
  • This is an onsite role based in Bedford, MA, requiring US work authorization and up to 10% travel.

Matching Summary

The Design Quality Engineer leads the entire design control process and executes comprehensive process validation strategies to ensure new products meet quality and regulatory standards.

Salary

Base: $102,480 to $163,968; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: PTO, 401k up to 7% match, HSA with company contribution, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • Design control process management
  • Process validation strategies
  • Risk management ISO 14971
  • CAPA process execution
  • Design verification and validation
  • Post Market Surveillance data analytics

Nice-to-have

  • Quality improvement project leadership
  • Quality management system development
  • Cross-functional team mentorship
  • Continuous improvement techniques
  • Regulatory compliance documentation

Key Requirements

  • Minimum 5+ years FDA regulated medical device experience
  • Bachelor’s Degree in Quality, Engineering or similar
  • Knowledge of Risk Management ISO 14971
  • Experience with Design Verification/Validation
  • Extensive CAPA process experience
  • US work authorization required
  • Proximity to Bedford, MA

Work Rights

US work authorization required, no sponsorship

Tailored Resume

Cover Letter