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 PQMS markets central team, you will drive QMS compliance in the markets and associated functions. Office location is Eindhoven, but you will be home-based.
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
- 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.
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
- Process engineering background with a good understanding of quality systems
- Experienced in the process as CAPA owner
- Good Technical Writing skills
- Data driven
- Very hand-on person
- Ability to work in different projects (CAPAs) at the same time
- Ability to interact in a multicultural environment
- Experience with Trackwise is a plus
- Experience in medical devices desired / proven experience on a high regulated environment
LOCATION: homebased (occasionally Eindhoven / Amsterdam)
If you are interested in the above description, apply with your CV
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For more information please contact Daria Petrova on +31 (0)20 20 44 502