Design Quality Engineer

Philips UK

Bedford, United States
Base: $102,480 to $163,968; bonus/equity: annual i...
Fully on-site
Design control process
Process validation strategies
Quality engineering documents
Philips UK is seeking a Design Quality Engineer based in Bedford, United States, to oversee the design control process for medical devices, ensuring compliance with quality and regulatory standards. The ideal candidate will have a minimum of five years' experience in FDA regulated environments, focusing on design assurance and risk management

Job Summary

  • The Design Quality Engineer is responsible for the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer, as well as leading comprehensive process validation strategies to ensure new products and current portfolio meet quality and regulatory standards during production.
  • Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
  • Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.

Matching Summary

Match Score: 85

Philips UK is seeking a Design Quality Engineer based in Bedford, United States, to oversee the design control process for medical devices, ensuring compliance with quality and regulatory standards. The ideal candidate will have a minimum of five years' experience in FDA regulated environments, focusing on design assurance and risk management.

Salary

Base: $102,480 to $163,968; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Comprehensive Philips Total Rewards benefits program including PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • Design control process
  • Process validation strategies
  • Quality engineering documents
  • Risk management activities
  • CAPA processes
  • Continuous improvement techniques

Nice-to-have

  • Integrate quality insights
  • Build effective relationships
  • Expert guidance and mentorship

Key Requirements

  • 5+ years FDA regulated medical device experience
  • Design Assurance/Control knowledge
  • Risk Management (ISO 14971) knowledge
  • QMS knowledge related to Design Controls
  • Design Verification/Validation experience
  • Root Cause analysis experience
  • Defect Management experience
  • CAPA processes experience
  • Bachelor’s Degree in Quality, Engineering or similar

Work Rights

US work authorization required

Tailored Resume

Cover Letter