Quality Systems Engineer

Philips

Bedford, MA, US
Base: $102,480 to $163,968; bonus/equity: annual i...
Fully remote
5+ years fda regulated experience
Iso 13485 quality operations
Capa process management
The role ensures an efficient and compliant Quality Management System (QMS) including audits, document control, and CAPA processes

Job Summary

  • The role ensures an efficient and compliant Quality Management System (QMS) including audits, document control, and CAPA processes.
  • Candidates must have at least 5 years of experience in FDA regulated medical device environments with a focus on ISO 13485 compliance.
  • Philips offers a comprehensive benefits program including generous PTO, a 401k match up to 7%, and stock purchase plans.

Matching Summary

The role ensures an efficient and compliant Quality Management System (QMS) including audits, document control, and CAPA processes.

Salary

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

Skills & Requirements

Must-have

  • 5+ years FDA regulated experience
  • ISO 13485 quality operations
  • CAPA process management
  • Root cause analysis expertise
  • QMS metrics and KPI analysis
  • Cross-functional team leadership

Nice-to-have

  • Mentoring less experienced engineers
  • Building stakeholder relationships
  • Innovative problem-solving approaches
  • Continuous learning engagement

Key Requirements

  • Minimum Bachelor's Degree in Quality or Engineering
  • US work authorization required without sponsorship
  • ASQ-CQE or ISO Lead Auditor certification desired
  • Reside in or commute to Bedford, MA

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter