Global CAPA Coach

Philips Iberica SAU; Cambridge (MA); Presencial; USD 134.000 - 213.000; Jornada completa

Descripción de la vacante

Philips is seeking a Global CAPA Coach in Cambridge, MA to lead CAPA training across our medical device programs. You will coach CAPA role holders, drive first-time-right execution, and strengthen regulatory compliance through consistent CAPA processes.

You will partner with global quality leaders and complete action reviews, monitor CAPA health metrics, and support audit readiness. Travel up to 50% may be required to support field and regional teams.

Formación

• Minimum 5 years of CAPA experience, including 3+ years as a CAPA facilitator/owner in medical devices.
• Knowledge of medical device regulations, CAPA and core QMS disciplines.
• Strong statistical, root-cause analysis and problem-solving skills.
• Proficiency with Excel, analytics and AI capabilities.
• Excellent verbal and written English communication; cross-functional collaboration.

Responsabilidades

• Train, coach, and advise CAPA role holders to ensure first time right CAPA execution.
• Develop and deliver CAPA training, coaching, and documentation.
• Partner with CAPA leaders and stakeholders through governance forums and reviews.
• Improve CAPA program performance by tracking effectiveness and trends.
• Communicate expectations and lessons learned using CAPA Playbooks and newsletters.

Conocimientos

CAPA leadership

Cross-functional leadership

Data analysis

Problem solving

Verbal communication

English proficiency

AI capabilities

Statistical analysis

Educación

Bachelor's degree

Lean Six Sigma

AI certifications

Herramientas

Excel

Descripción del empleo

Job Title

Global CAPA Coach

Job Description

Global CAPA Coach

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.

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.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

We believe that we are better together than apart. For our office‑based teams, this means working in‑person at least 3 days per week. Onsite roles require full‑time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office‑based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Gainesville, FL, Murrysville, PA, and Nashville, TN is $120,000 to $190,000.

The pay range for this position in Chicago, IL, and Plymouth, MN is $126,000 to $200,000.

The pay range for this position in Cambridge, MA is$134,000 to $213,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job‑related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long‑term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.