Senior CAPA Engineer (Freelance)
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.
- Ability to assess risk as it pertains to the CAPA
- Reviews CAPA records from other Facilitators to provide peer feedback.
- 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. Our 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 8 years of experience working in quality at a medical device design/manufacturer
- Strong Project Management skills, including ability to project manage all CAPA activities.
- Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
- 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
- Ability to communicate ideas and information clearly, effectively and concisely