Philips CAPA Specialist / Engineer 

India, Maharashtra 

998397515

CAPA Specialist / Engineer

Your role:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

• 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.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

• Work effectively 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:

• Bachelor’s or Masters degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence

• 5+ year of experience in medical device or other regulated industry. Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971

• Good project management & stake holder management skills

• Qualified expert with good experience in the CAPA engineering field

• Structured & process-oriented individual with ability to apply company policies and procedures to resolve a variety of issues

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.
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