R&D CAPA Manager

Job Title

Job Description

Job title:
R&D CAPA Manager
Your role:

1. CAPA Execution & Ownership

• Own end-to-end execution of assigned R&D CAPAs (intake, investigation, action definition, implementation, verification of effectiveness).
• Ensure CAPAs are completed on time, within scope, and meet quality and compliance standards.
• Drive high-quality root cause analysis using structured methodologies, e.g., 5 Whys, Fishbone, Fault Tree or advanced statistical methods.
• Define and implement effective corrective and preventive actions that address systemic issues.
• Ensure proper documentation and traceability in quality systems.

2. Investigation & Problem Solving

• Lead or support complex investigations related to design, process, or system issues.
• Collaborate with R&D, Quality, Regulatory, and other functions to gather data and insights.
• Challenge insufficient problem statements or weak root cause definitions.
• Ensure alignment between identified root causes and implemented actions.

• Track CAPA progress and proactively manage risks, delays, and escalations.
• Ensure compliance with applicable regulations and standards (e.g., ISO 13485, FDA QMSR, MDR).
• Support audit and inspection readiness by ensuring CAPA documentation is complete and defensible.
• Participate in audit/inspection responses related to CAPA topics.

• Analyze CAPA data to identify recurring issues and systemic trends.
• Provide insights to improve R&D processes, design practices, and quality systems.
• Contribute to continuous improvement initiatives within R&D Quality Operations.
• Support development and refinement of CAPA processes, templates, and tools.

5. Cross-functional Collaboration

• Act as operational interface between R&D teams, Quality, Regulatory Affairs, and other stakeholders.
• Facilitate alignment on CAPA scope, actions, and timelines.
• Support resolution of cross-functional and cross-regional quality issues.
• Communicate progress, risks, and outcomes clearly to stakeholders.

6. Process & Systems Utilization

• Ensure accurate and timely use of CAPA and quality management systems.
• Maintain high standards of data integrity and documentation quality.
• Contribute to digitalization and optimization of CAPA workflows.

8. Key Deliverables

• Timely and compliant closure of assigned CAPAs.
• High-quality investigation reports with clear root cause and rationale.
• Effective corrective and preventive actions with demonstrated impact.
• Reliable CAPA data and documentation supporting audits and inspections.
• Contributions to systemic quality improvements in R&D.

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You're the right fit if: (4 x bullets max)

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• 3-8+ years of experience in R&D, Quality, or Design Assurance in a regulated industry.
• Hands-on experience with CAPA processes and root cause analysis.
• Familiarity with quality standards (e.g., ISO 13485, FDA QMSR, MDR).
• Experience working in cross-functional environments.

10. Competencies

11. Technical & Operational

• Strong CAPA methodology and problem-solving skills
• Root cause analysis expertise
• Understanding of R&D and design control processes
• Data-driven decision making
• Quality system and regulatory knowledge

12. Collaboration & Influence

• Effective cross-functional collaboration
• Ability to challenge constructively and drive clarity
• Clear and structured communication
• Stakeholder management without formal authority

13. Personal Effectiveness

• Strong ownership and accountability
• Structured and disciplined execution
• Attention to detail and documentation rigor
• Resilience under pressure and deadlines
• Continuous improvement mindset

14. Success Factors

Success in this role depends on the ability to translate quality issues into clear problem statements, drive rigorous investigations, and ensure actions eliminate root causes-not just symptoms.

The engineer must balance speed and compliance, ensuring CAPAs are closed on time while maintaining depth and quality. Strong cross-functional alignment and persistence are critical to prevent superficial fixes and recurring issues.

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.
Indicate if this role is an office/field/onsite 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 the lives of others.
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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

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