Operations Quality Manager

Philips UK

Fremont, CA, United States
Base: $103,000 to $163,968; bonus/equity: annual i...
Fully remote
5+ years fda regulated medical device experience
Operations quality iq/oq/pq expertise
Capa activities and internal/external audit programs
The Operations Quality Manager will manage the Quality Operations team and coordinate activities to ensure alignment with corporate goals and regulatory compliance for Philips' Image Guided Therapy Devices

Job Summary

  • The Operations Quality Manager will manage the Quality Operations team and coordinate activities to ensure alignment with corporate goals and regulatory compliance for Philips' Image Guided Therapy Devices.
  • This role involves driving quality investigations, reviewing corrective action plans, and leading CAPA activities while supporting internal and external audit programs.
  • Employees are eligible to participate in a comprehensive benefits program including generous PTO, a 401k match up to 7%, and an HSA with company contribution.

Matching Summary

The Operations Quality Manager will manage the Quality Operations team and coordinate activities to ensure alignment with corporate goals and regulatory compliance for Philips' Image Guided Therapy Devices.

Salary

Base: $103,000 to $163,968; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match up to 7%, HSA with company contribution, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • 5+ years FDA regulated medical device experience
  • Operations Quality IQ/OQ/PQ expertise
  • CAPA activities and internal/external audit programs
  • ISO 13485/14971 and 21CFR knowledge
  • Root cause analysis and product impact assessments
  • Bachelor's degree in Quality or Engineering

Nice-to-have

  • ASQ certifications preferred
  • Functional team management experience desired
  • Budgeting and workforce planning skills
  • Employee engagement and retention focus
  • Succession planning and coaching abilities

Key Requirements

  • Minimum 5+ years in FDA regulated medical device environments
  • Bachelor's degree in Quality, Engineering, or related scientific discipline
  • US work authorization required without sponsorship eligibility
  • Reside in or within commuting distance to Fremont, CA

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter