Philips Senior Quality Engineer- CAPA Expert 

South Africa, Free State, Dihlabeng Local Municipality 

581997481

Senior Quality Engineer- CAPA Expert

In this role you

CAPA subject matter expert who can confidently advise and critically review Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.

Your role:

• Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow
• Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
• Support updating the business processes relating to CAPA. Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings
• Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving. Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines

You're the right fit if:

• Bachelor’s degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment. 5+ years’ practical experience with CAPA
• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
• Strong Project Management skills, including ability to project manage all CAPA activities
• 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

This is an office role.

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.

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The pay range for this position In Cambridge is $89,000 to $127,000, Annually.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance to Cambridge MA