Philips Senior CAPA Manager 

South Africa, Free State, Dihlabeng Local Municipality 

1166459

Senior CAPA Manager

Your role:

• You will Manage, lead and mentor cross functional teams of CAPA Facilitators with the implementation of appropriate root cause analysis techniques, Project manage all aspects of CAPA activity, which includes gaining the commitment of cross functional resources, scheduling team meetings, ensuring deliverables per project timelines, ensure the quality of CAPA record content and represent CAPA’s during audits and CAPA Review Board meetings.
• You will facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
• You will analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• You will work with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.

You're the right fit if:

• You have a minimum of 8 years’ experience focused on Corrective and Preventative Actions (CAPA) in FDA regulated medical device/product environments, with a minimum of 3 years’ functional management experience, developing and mentoring high performing quality teams.
• You’re able to understand and analyze complex problems, including software and hardware design issues and have demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
• You have a 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.
• You’ve demonstrated strong CAPA Project Management skills, including the ability to analyze data/apply statistical techniques and ability to partner with the business and effectively interact with/ influence employees, and managers on all levels.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines, Master’s Degree desired. ASQ certifications-Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or DfSS Green Belt/Black Belt preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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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Philips Transparency Details:

• The pay range for this position in Cambridge, MA is $116,000 to $200,000.

Additional Information

• 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.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, MA.