CAPA Engineer

Job Title
CAPA Engineer

Job Description

As a QMS Specialist - CAPA , you’ll take ownership of key quality processes to ensure our CAPAs runs smoothly, efficiently, and in full compliance with industry standards. Working with a high level of independence, you’ll analyze corrective and preventive actions plans & investigations, prepare insightful reports, and present recommendations directly to senior management. You’ll play a hands-on role in shaping and refining QMS CAPAs, driving continuous improvement, and finding smart solutions to complex challenges.

Your role:
• Takes ownership of basic processes in the assigned area/areas (Audits, CAPA) to ensure that QMS is efficient and meets the QMS/CAPA and regulatory requirements.
• Analyzes CAPA metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality, and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

You're the right fit if:
•Bachelor's / master’s degree in a relevant field

•Minimum 5 years of experience in areas such as CAPA, Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.

• Fluency in English.

•Fluency in German is an advantage.

Preferred Skills:
• Quality Management Systems (QMS)
• Project Management
• Troubleshooting
• KPI Monitoring and Reporting
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Regulatory Requirements
• User Training & Support
• Training Content Development
• Regulatory Requirements

*The position isn't open for relocation

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.

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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