Global CAPA Coach
Philips
Summary
The Global CAPA Coach serves on the Global CAPA Process Team within Philips Quality & Regulatory, developing training and coaching 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.
Job description
Your role
- Train, coach, and advise CAPA role holders and teams to drive first time right CAPA execution, complete and accurate documentation, regulatory compliance, and consistent application of the CAPA process across the enterprise.
- Develop, deliver, monitor, and continuously improve instructor-led training, coaching, communications, record reviews, audit and inspection readiness, change management, and problem-solving using the CAPA Checklist, risk management, QMS management, complaint handling, correction and removal, design, manufacturing, and service processes.
- Partners with the CAPA BPO/BPE, Business, Factory, Regional and Quality leaders, CAPA process owners, QMS stakeholders, senior leadership, and the broader CAPA Community through coaching, quarterly reviews, workshops, governance forums, community meetings, and audit support.
- Improve CAPA program performance, culture, consistency, and audit readiness by tracking action effectiveness and monitoring CAPA health metrics, trends, aging, record quality, recurrence, training impact, systemic risks, and adoption of updated processes and tools.
- Use SharePoint, Engage, CAPA Playbooks, One-Point Lessons, newsletters, presentations, analytics, CAPA governance resources, and recognition programs to communicate expectations, share lessons learned, support informed decisions, and reinforce continuous improvement.
You're the right fit if
- Minimum 5 years of relevant experience, including at least 3 years as a CAPA Facilitator, Manager, or Owner in the medical device industry, with experience managing product, process, and complex CAPAs.
- Practical knowledge of medical device regulations, CAPA, and core QMS disciplines, including production and process quality control, design, complaint handling, correction and removal, and post-market surveillance, along with strong statistical, root-cause analysis, effectiveness-check, sampling, simulation-modeling, Excel, analytics, and AI capabilities.
- Bachelor's degree in a technical field required; auditor, Lean Six Sigma Black Belt or Green Belt, and AI certifications are preferred.
- Strong attention to detail and systemic thinking, with demonstrated cross-functional leadership, collaboration, coaching, mentoring, problem-solving, organization, technical writing, presentation, workshop facilitation, and clear verbal and interpersonal communication skills in English.
- Willing and able to travel up to 50% as required by business needs.
Requirements
- Minimum 5 years of relevant experience
- At least 3 years as a CAPA Facilitator, Manager, or Owner in the medical device industry
- Experience managing product, process, and complex CAPAs
- Practical knowledge of medical device regulations, CAPA, and core QMS disciplines
- Knowledge of production and process quality control, design, complaint handling, correction and removal, and post-market surveillance
- Strong statistical, root-cause analysis, effectiveness-check, sampling, simulation-modeling, Excel, analytics, and AI capabilities
- Bachelor's degree in a technical field required
- Strong attention to detail and systemic thinking
- Demonstrated cross-functional leadership, collaboration, coaching, mentoring, problem-solving, organization, technical writing, presentation, workshop facilitation, and clear verbal and interpersonal communication skills in English
- Willing and able to travel up to 50%
Benefits
- Paid time off
- 401(k) up to 7% match
- Health savings account
- Stock purchase plan
- Education reimbursement
Company overview
Koninklijke Philips N.V., commonly known as Philips, is a Dutch multinational health technology company that has evolved from its origins as a consumer electronics conglomerate into a leading global healthcare solutions provider. Founded in 1891 in Eindhoven, Netherlands, Philips has transformed its business focus since the 2010s to concentrate exclusively on health technology. The company operates through three main divisions: Diagnosis and Treatment, which manufactures advanced medical imaging equipment including MRI, CT, and ultrasound scanners; Connected Care, specializing in patient monitoring systems and respiratory care products under the Respironics brand; and Personal Health, producing consumer healthcare products like electric shavers, Sonicare toothbrushes, and Avent childcare items. With 68,419 employees worldwide and annual revenues of €18.02 billion (2024), Philips maintains its global headquarters in Amsterdam while operating manufacturing, R&D, and sales facilities across 26 countries. The company has strategically divested its consumer electronics, lighting, and home appliance businesses to become a pure-play health technology organization, positioning itself at the forefront of medical innovation and digital healthcare solutions.