Post Market CAPA Manager
Post Market CAPA Manager
In this role, you have the opportunity to
Guide and support all MA&TC Business Groups with regards to post market CAPA investigations and requirements. This involves being a confident advisor on approval, regulatory compliance and quality management for post market related CAPAs. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
You are responsible for
- Facilitate product and process Post Market specific 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 Post Market 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, fishbone diagrams, 5 whys).
- 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 and subject matter experts to ensure CAPA action plans are comprehensive and executable.
- Use experience in Post Market (complaints, risk management, field actions) to write comprehensive CAPA reports in CAPA tool (Trackwise).
You are a part of
A Quality Team which enables meaningful innovation to our customers by partnering with and guiding the business to achieve world class quality and full regulatory compliance. We do this while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree in an Engineering or Science related field or equivalent technical experience.
- At least 3 years of experience in Medical Device or regulated industry.
- Experience in managing all aspects of a CAPA investigation and be able to evaluate compliance to regulations.
- Experience in medical device Post market functionality and compliance (complaint handling, field actions, risk management)
- Strong Project Management skills, including the ability to project manage all CAPA activities.
- 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.
- Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
- Able to understand and analyze complex problems, including software and hardware design issues.
- Ability to analyze data and apply statistical techniques.
- Excellent written and verbal communication skills.
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to impact worldwide regulatory compliance and directly improve the customer and patient experience.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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