My client is a global MedTech manufacturer located in Brabant. They strive to develop new technologies in the healthcare field, using state-of-the-art technology for customers and stakeholders all around the world. They are market leading in medical IT applications, patient monitoring, home health care systems and other health related areas.
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
In this role, you have the opportunity to guide and support business groups, markets and enabling functions to always do the right thing. As a QMS (Quality Management System) Manager within the QMS markets central team, you will drive QMS compliance in the markets and associated functions. Office location is Eindhoven, but you will be home-based.
- Act as a Project Manager with internal CAPA owners to manage all aspects of CAPA activities which include gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.
- 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.
- Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
- Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency Represent CAPAs during audits and CAPA Review Board meetings.
- Bachelors’ degree in Engineering or scientifc related field
- 3+ years’ work experience in quality functions
- Experience in Medical Devices / Highly regulated Industry
- Experience in managing projects in a technical and innovative environment
- Experience in Trackwise is considered a plus