Job Title
CAPA Specialist / Engineer
Job Description
You are a part of Monitoring business cluster focusing on development of hardware designs for a common platform serving multiple product lines based in Baner, Pune. Healthcare Innovation Center (HIC) is playing a key role in Philips global strategy for patient monitoring businesses.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
You have the opportunity for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.
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
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 commitment to diversity and inclusion here.
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