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.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.