In this role, you have the opportunity to
Utilize your experience in quality engineering to drive continuous improvement within Philips to ensure capa activities can support our business needs
You are responsible for
Perform initial assessments and lead thorough root cause investigations of newly opened CAPA requests
Work with Subject Matter Experts and Element Owners as needed to gather information and investigate issues
Gathering data from many systems for analysis
Review completed investigations for CAPA Review Board
Independently produces and completes CAPA record
Ability to assess risk as it pertains to the CAPA
Responsible for performing timely, detailed CAPA engineering tasks including: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
Represent CAPAs during audits and CAPA Review Board meetings.
Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
At least 3 years’ experience with CAPA
Able to manage multiple complex projects simultaneously while maintaining a professional attitude and deliver results.
Able to understand and analyze complex problems, including software and hardware design issues.
Demonstrated knowledge of tools and techniques including FMEA, Fishbone/Ishikawa, etc. 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 14971, and EU MDR.
Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
Strong Project Management skills, including ability to project manage all CAPA activities.
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. 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.
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.
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