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Philips

Makes medical devices and personal health products

Global CAPA Coach

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • At least 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.
  • Strong statistical, root-cause analysis, effectiveness-check, sampling, simulation-modeling, Excel, analytics, and artificial intelligence capabilities.
  • A bachelor's degree in a technical field is required.
  • 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.
  • Willingness and ability to travel up to 50% as required by business needs.
  • Must be able to successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodation.

Responsibilities

  • 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.
  • Partner 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.

Desired Qualifications

  • Auditor certification is preferred.
  • Lean Six Sigma Black Belt or Green Belt certification is preferred.
  • Artificial intelligence certifications are preferred.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
IPO
Headquarters
Andover, MN
Founded
1891

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