Operations Quality Manager

Philips

Fremont, CA, US
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 requires implementing policy changes, managing manufacturing processes, and leading corrective action plans while fostering a culture of excellence and continuous improvement within the organization.
  • Employees are eligible to participate in a comprehensive benefits program including generous PTO, a 401k match up to 7%, HSA contributions, and stock purchase plans.

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, sales commission, or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA, 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
  • Bachelor's degree in Quality or Engineering
  • Root cause analysis and product impact assessments

Nice-to-have

  • ASQ certifications preferred
  • Functional team management experience desired
  • Budgeting and workforce planning skills
  • Succession planning and employee engagement
  • Strong cross-functional collaboration abilities
  • Continuous improvement culture fostering

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 future sponsorship eligibility
  • Reside in or commute from Fremont, CA
  • Experience with ISO 13485, 14971, MDD/EU MDR, cGMP standards

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter