Director Of Quality, Compliance And Audit

Philips UK

Cambridge, MA, US
Base: $162,000 to $286,960 depending on location; ...
Fully remote
15+ years medical device industry experience
Fda 21 cfr part 820 regulatory knowledge
Iso 13485 and iso 9001 compliance expertise
Philips UK is seeking a Director of Quality, Compliance, and Audit to lead global compliance initiatives, internal audits, and quality systems within their medical device sector. The ideal candidate should possess extensive experience in compliance engineering and quality systems, especially within the medical device industry

Job Summary

  • This role leads the global Internal Audit program and shared services Compliance Engineering function across the Philips Quality Enterprise Services organization.
  • The position is accountable for ensuring proactive compliance with regulatory requirements through robust quality systems and risk-based methodologies.
  • Employees are eligible to participate in a comprehensive benefits program including a generous PTO, 401k match up to 7%, and stock purchase plans.

Matching Summary

Match Score: 85

Philips UK is seeking a Director of Quality, Compliance, and Audit to lead global compliance initiatives, internal audits, and quality systems within their medical device sector. The ideal candidate should possess extensive experience in compliance engineering and quality systems, especially within the medical device industry.

Salary

Base: $162,000 to $286,960 depending on location; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k up to 7% match, HSA, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • 15+ years medical device industry experience
  • FDA 21 CFR Part 820 regulatory knowledge
  • ISO 13485 and ISO 9001 compliance expertise
  • Global internal audit program leadership
  • Compliance Engineering and CAPA management
  • Regulatory inspection readiness preparation

Nice-to-have

  • Advanced data analytics and predictive insights
  • Strategic leadership in matrixed organizations
  • Engineering-driven problem solving skills
  • Digitalization of quality management systems
  • Team development and succession planning

Key Requirements

  • Minimum 15 years experience in medical device industry
  • Bachelor's degree required; Master's preferred
  • US work authorization required without sponsorship
  • Deep knowledge of FDA 21 CFR Part 820
  • Experience supporting FDA and Notified Body inspections

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter