CAPA Project Manager

CAPA Project Manager

As a CAPA Project Manager in Philips’ Image Guided Therapy (IGT) business unit, you will play a key role in safeguarding the quality, safety, and compliance of our service and product offerings. You will lead and manage CAPA (Corrective and Preventive Actions) initiatives that address complex quality and process issues in the field.

This role combines hands-on ownership of CAPA cases with project management responsibility over multiple CAPA projects. It requires strong problem-solving skills, a structured methodology, and the ability to drive cross-functional collaboration across quality, service, and engineering teams.

Key Responsibilities:

• CAPA Leadership & Ownership (50%)

  • Act as CAPA Owner: lead investigation, root cause analysis, and implementation of corrective/preventive actions.

  • Facilitate cross-functional teams through structured problem-solving processes.

  • Apply tools like 5 Whys, Fishbone, and Decision Trees to identify root causes and drive sustainable solutions.

• CAPA Project Management (50%)

  • Oversee multiple CAPA projects to ensure progress, stakeholder alignment, and timely closure.

  • Support other CAPA Owners with planning, coordination, and reporting.

  • Ensure CAPA phases are completed according to plan, with clear documentation and follow-through.

• Root Cause Analysis & Data Analysis

  • Analyze quality data to identify trends and risks (e.g., complaints, field issues, installed base data).

  • Use insights to guide problem-solving and preventive actions.

• Documentation & Reporting

  • Ensure complete, concise, and compliant CAPA documentation for audits and regulatory inspections.

  • Track and report CAPA status, metrics, and outcomes to relevant stakeholders.

• Regulatory & Quality Compliance

  • Ensure CAPAs meet internal quality standards and external regulations (FDA QSR, ISO 13485).

  • Actively contribute to audit readiness and quality system improvements.

• Continuous Improvement

  • Drive process improvements across the CAPA lifecycle.

  • Foster a quality-first mindset and build a culture of proactive risk mitigation and learning.

Qualifications and Skills:

• Bachelor’s or Master’s degree in Engineering, Quality, Health Sciences, or a related field.

• Minimum 10 years of relevant experience, ideally in a regulated industry (e.g. medical devices or service delivery).

• Deep understanding of the CAPA process and structured problem-solving methodologies.

• Experience with RCA tools (Fishbone, 5 Whys, FMEA, etc.) and quality management systems.

• Strong project management and stakeholder engagement skills.

• Ability to deconstruct complex issues into actionable solutions with support from subject matter experts.

• Excellent communication and documentation skills.

• Knowledge of applicable regulatory standards (FDA QSR, ISO 13485, GMP).

• Certifications (e.g., Six Sigma, ASQ CQE) are a plus.

Work environment:

• You will be part of the IGT Services and Solutions Delivery.

• Work can be performed in a hybrid way of working (remote and on location in Best)

Benefits:

• Job Grade 70 with excellent growth opportunities.

• Opportunities for professional development and training.

• Chance to significantly impact product quality and patient outcomes in the healthcare industry.

Additional Information:

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise, and become an even more sought-after professional, you’ll find all that and more with project work

Hybrid way of working: min of 3 days at the office in Best.

Please make sure the submitted candidates at least meet these minimum requirements:

Education

Bachelor's / Master's Degree in Health Science, Engineering or Information Systems or equivalent.

Work Experience

Minimum 2 years of experience with Bachelor's OR Minimum 1 years of experience with Master's in areas such as Service Delivery or equivalent.