Personal Health QMS Audit and CAPA Manager

Job Title

Job Description

Your role:

• Oversees the overall functioning of the QMS Audit and CAPA team, across Personal Health Businesses, Regions and Functions, ensuring efficient execution of quality processes and strict adherence to company policies and other necessary requirements.
• Acts as the Personal Health CAPA process owner, the main Personal Health CAPA Review Board Chair and coordinate activities between subordinate Personal Health CAPA Review Boards, fostering a culture of quality excellence and operational efficiency throughout the organization
• Setup, manages and continuously improves and simplify the Personal Health Internal and External Audit programs
• Analyzes QMS performance data, related to CAPA and Audit, to identify trends, systemic issues, and (strategic) improvement opportunities, and leads cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.
• Serves as a senior quality advisor and key point of contact for regulatory and certifying bodies, ensuring that QMS processes and practices are fully compliant, and effectively managing external audits, inspections, and follow-up actions.
• Leads and manages complex, high-impact problem-solving initiatives using advanced quality tools and methodologies such as Six Sigma or Lean, ensuring effective resolution of critical quality issues and sustainable improvements.
• Facilitates cross-functional collaboration to address and resolve critical quality issues, ensuring alignment between departments and effective implementation of solutions.
• Oversees the management and resolution of non-conformances, ensuring systematic tracking, thorough investigation, effective resolution, and implementation of preventive measures.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.

You're the right fit if you have:

• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent
• Minimum 5 years of experience in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive
• People management experience
• Regulatory Requirements and Compliance – ISO9001, ISO13485, MDSAP
• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• KPI Monitoring and Reporting
• Continuous Improvements
• Simplification mindset
• Business Acumen
• Stakeholder Management
• Change Management
• Communication
• Flexibility working across different Businesses, Regions and Functions, jurisdictions and time zones

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

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