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Sr. CAPA Engineer

In this role, you have the opportunity to

Make a substantial contribution to the improvement and maintenance of the Philips Ultrasound QMS.

You are responsible for

• Facilitate the Corrective and Preventive Action (CAPA) program by leading and mentoring cross-functional teams through appropriate root cause analysis and action plan development and identification of effectiveness criteria.

• Apply sound, systematic problem-solving methodologies in identifying, communicating, and resolving quality issues.

• Responsible for maintaining CAPA records and keeping them in a state of audit readiness.

• Manage CAPA schedules to ensure CAPA deliverables are met on time.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Document all phases of CAPA activity in compliance with applicable standards including 21 CFR part 820.100 and ISO 13485, and procedural requirements.

• 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.

• Serve as TrackWise tool SME.

You are a part of

The Philips Ultrasound Team. O ur mission is to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Our QMS is an enabler for this mission.

To succeed in this role, you should have the following skills and experience

• A minimum of a Bachelor's Degree in a Science/Engineering or other relevant technical discipline with 5+ years of experience working in quality at a medical device design/manufacturer

• Minimum of 2 years owning CAPAs

• Extensive experience conducting and documenting failure investigations

• Experience with the use of electronic CAPA tool

• Six Sigma training/certification is a plus

• Thorough knowledge and understanding of global Medical Device standards and regulations including FDA QSR and ISO13485:2016

• Ability to interact professionally with all organizational levels

• Must be results-driven – Able to manage competing priorities in a fast-paced environment

• Ability to communicate ideas and information clearly, effectively and concisely

• Highly detailed oriented with strong organization and prioritization skills

In return, we offer you

The opportunity to work in a global environment – partnering across functions, teams, businesses and geographies. You will be challenged to support and deploy changes to the QMS needed to meet the ever-evolving regulatory requirements for Medical Device manufacturers.

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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