Global CAPA Coach

Philips•Gainesville, FL

10d•$120,000 - $213,000•Hybrid

About The Position

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.

Requirements

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.
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.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to posted locations.

Nice To Haves

Bachelor’s degree in a technical field required; auditor, Lean Six Sigma Black Belt or Green Belt, and AI certifications are preferred.

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.
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.