Quality Engineer - CAPA
Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring
the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.
• Facilitate product and process 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 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).
• 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.
- Bachelors degree in an engineering or scientific discipline, or equivalent experience
- Working knowledge of appropriate global medical device regulations and standards
- 3+ years experience in a regulated industry (medical device, IVD)
- 3+ year working in the area of quality management systems and/or regulatory affairs
- Experience in CAPA management and problem solving
- Strong personal skills demonstrating structured and self-organized way of working
- Ability to communicate effectively both orally and in writing with subject matter experts and other functional areas.
- Strong analytical and process focused thinking skills
- Ability to work in a virtual team and within a cross functional global organization
- Demonstrate Philips behaviours
Depending on your work experience and educational level, we offer you a gross salary of €3.800 – €4.800 per month. Besides this, we offer a healthy work-life balance with flexible hours and possibility to work from home. We also offer other benefits, such as collective discount on health insurance and a good pension scheme. At YACHT, we value personal development and we will help you to get to that next stage of your career.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.