Terumo Aortic are currently looking to recruit a Quality Engineer (NCR/CAPA) to join our team. This role will provide Quality Engineering support to the NCR/CAPA processes including development of containment plans / investigation plans / root cause analysis / action plans / effectiveness plans and perform NCR/CAPA trend analysis. This is a fantastic opportunity to join our business during a time of growth and investment on-site. Offering fantastic career development opportunities and a chance to make real difference.
The main responsibilities of the role are;
1. Maintain the management tools (trackers, electronic folder, etc) to ensure audit readiness
2. Provide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriate
3. Act as CAPA team owner/facilitator throughout all phases of activities such as initiation, investigation, action plan and effectiveness
4. Act as NCR team owner/facilitator throughout all phases of activities such as initiation, risk assessment, investigation and disposition
5. Provide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigations
6. Provide guidance and support for robust effectiveness measurement of CAPA / NCR actions
7. Maintain communication channels with the CAPA / NCR owners regarding time frames and progression updates.
8. Support development of solution verification tools to validate CAPA / NCR action plans
9. Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated
10. Generate and maintain trending data for the CAPA / NCR process and publish as part of QMS KPI dashboard Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
11. Provide data trending information and status updates to the respective CAPA and NCR Review Boards
12. In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR data
13. Work towards meeting departmental and facility objectives
14. Participate in facility Internal Audit programme
15. Development of cross-functional and collaborative relationships within the facility
16. Creating new policies or procedures to improve efficiency in CAPA / NCR handling.
17. Development of effective internal relationships to ensure quality and regulatory compliance for the business
The successful candidate will possess;
18. Relevant science / engineering degree
19. Six Sigma qualified – minimally Green Belt level (desirable)
20. Knowledge and understanding of applicable regulations especially with regards to Non Conformance, CAPA, Root Cause Analysis and Trending
21. Class III medical device knowledge (desirable)
22. Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
23. Working knowledge of Minitab or similar statistical tool (desirable)
24. Experience of FDA regulations
25. Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
26. Strong analytical and problem-solving skills, including appropriate use of statistical techniques
27. Excellent facilitation, coordination, prioritising, and communication skills
28. Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
29. Competent in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department