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:
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.
May lead a team of individual investigators to support the Monitoring Analytics
Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
Must be able to address multiple CAPAs simultaneously
Responsible for maintaining and updating CAPA business processes.
Independently produces and completes CAPA record, ensuring compliance with applicable external regulations and internal standards, while assuring agreement within the organization.
Ensures disagreements within CAPA records are reconciled, including appropriate escalation as required.
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.
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 and tasked to the projects.
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
5+ years’ experience with CAPA and at least 6 years’ experience in a medical device or other FDA-regulated industry.
Demonstrated expert knowledge of tools and techniques required to perform thorough root cause analysis and document strong investigations.
Able to understand and analyze complex problems, including quality management system and software / hardware design issues.
Strong understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, ISO 14971, EU Medical Device Regulations (EUMDR).
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
ASQ Certification such as Certified Quality Engineer or Certified Quality Auditor, or DfSS Green Belt / Black Belt.
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.
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.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.