Senior Quality Manager-CAPA

Job Title

Senior Quality Manager-CAPA

Job Description

The Senior Quality Manager-CAPA will play a critical role within Philips’ Global Patient Safety & Quality organization by leading and managing the Corrective and Preventive Action (CAPA) Program/Team for our global operations.

Your role:

• CAPA Program/Team Leadership: Will own/manage the global CAPA process, ensuring timely identification, investigation, and resolution of quality issues. Oversees the root cause analysis process, applying best practices such as 5 Whys, Fishbone, FMEA, and other problem-solving methodologies. Ensures CAPA actions are effective, sustainable, and verified according to established quality system procedures. Develop and monitor key CAPA metrics (e.g., aging reports, effectiveness checks) to assess program performance and identify areas for improvement.
• Global Quality Oversight: Provides strategic leadership and governance for CAPA activities across multiple regions, ensuring consistency and compliance with corporate quality standards. Will collaborate with the CAPA Center of Excellence and other Quality Managers to align CAPA processes and share best practices. Serves as the CAPA subject matter expert (SME) during internal and external audits, including FDA, ISO 13485, and other regulatory inspections.
• Regulatory Compliance & Documentation: Ensures CAPA program adherence to global regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable regulations. Drives continuous improvement initiatives to enhance CAPA system robustness and documentation practices. Prepares and presents CAPA reports to senior leadership, providing insights on trends, risks, and mitigation strategies.
• Cross-Functional Collaboration: Will partner with Service, Sales, Marketing, Engineering, Manufacturing, and Quality teams to address systemic issues and implement effective preventive actions. Drives design for quality initiatives by integrating CAPA learnings into product development and manufacturing processes. Leads and mentors a team of quality professionals, providing guidance on CAPA investigations and documentation.

You're the right fit if:

• You have a minimum of 10+ years’ experience in Quality Assurance/Engineering, within FDA regulated medical device environments, with proven functional leadership experience and expertise in CAPA program management, root cause analysis, corrective actions, End to End QMS, Post Market Surveillance, Design Control and verification of effectiveness.
• You have In-depth knowledge of global medical device regulations (FDA, ISO 13485, MDR), industry standards and experience in managing/presenting during regulatory audits.
• You have strong analytical/problem-solving skills, with proficiency in quality tools and statistical analysis.
• You have excellent leadership, communication, and cross-functional collaboration abilities.
• You’re experienced with electronic quality management systems (QMS).
• You have strong project management skills (MS Project preferred) with the ability to lead multiple initiatives simultaneously.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering (Mechanical, Biomedical, Electrical) or a related technical discipline. Certified Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) desired.
• 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 a part. 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 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 busines