Senior Design Assurance Engineer

Philips UK

San Diego, United States
Base: $123,000 to $243,400 annually; bonus/equity:...
On-site
Design assurance process
Quality management system (qms)
Risk management files
As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices

Job Summary

  • As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices.
  • Create and update new product risk management deliverables including Risk Management Files, Risk Management Plans, Use FMEAs, Design FMEAs and Risk Management Reports.
  • We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.

Matching Summary

As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices.

Salary

Base: $123,000 to $243,400 Annually; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • Design Assurance process
  • Quality Management System (QMS)
  • Risk Management Files
  • EU MDR readiness
  • statistical expertise

Nice-to-have

  • working in-person at least 3 days per week
  • health technology company

Key Requirements

  • Bachelor's / Master's Degree
  • 3+ years experience in Quality Assurance
  • medical device industry experience
  • Working knowledge of medical device regulations
  • Working knowledge of new product design and development
  • Working knowledge of risk management application

Work Rights

US work authorization required

Tailored Resume

Cover Letter