Global CAPA Coach
philips · Cambridge (US)
Job description
About the role
The Global CAPA Coach serves on the Global CAPA Process Team within Philips Quality & Regulatory, developing training and coaching for CAPA role holders to strengthen execution, compliance, quality, and timeliness. The role partners with business, factory and regional quality leaders to plan and implement improvements that enable diverse global teams to deliver effective, first‑time‑right CAPAs supporting patient safety and quality.
Key responsibilities
- Train, coach and advise CAPA role holders and teams to drive first‑time‑right CAPA execution, accurate documentation and regulatory compliance.
- Develop, deliver and continuously improve instructor‑led training, coaching, communications, record reviews, audit readiness and problem‑solving using CAPA checklists and QMS processes.
- Partner with CAPA BPO/BPE, business, factory, regional and quality leaders, senior leadership and the broader CAPA community through coaching, quarterly reviews, workshops and governance forums.
- Improve CAPA program performance, culture and audit readiness by tracking action effectiveness, health metrics, trends, aging, record quality and systemic risks.
Required profile
- Minimum 5 years of relevant experience, including at least 3 years as a CAPA Facilitator, Manager or Owner in the medical device industry.
- Practical knowledge of medical device regulations, CAPA and core QMS disciplines such as production quality control, design, complaint handling and post‑market surveillance.
- Bachelor’s degree in a technical field; auditor, Lean Six Sigma Black Belt or Green Belt and AI certifications are preferred.
- Strong attention to detail, systemic thinking and demonstrated cross‑functional leadership, coaching and clear communication in English.
Required skills
- Statistical analysis
- Root‑cause analysis
- Effectiveness checking
- Sampling and simulation modeling
- Excel
- Analytics
- AI capabilities
- SharePoint
What we offer
- Salary range $134,000 – $213,000 per year (US)
- Annual incentive bonus and long‑term incentive opportunities
- Comprehensive Philips Total Rewards benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan and education reimbursement
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Published 1 week ago
Expires 1 month from now
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philips
Cambridge (US)
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