Quality Assurance Leader Role
To lead quality assurance and supplier quality engineering efforts to ensure compliance with relevant procedures.
This includes process/supplier validation, change requests, non-conforming product issues, corrective and preventive action programs, risk assessment, and quality system documentation.
1. Drive all assigned supplier quality engineering projects ensuring they are managed in a structured fashion and completed in compliance with relevant procedures.
2. Manage project activities to ensure timely completion of project milestones.
3. Represent team at key review meetings.
4. Build effective relationships with other functions including operations, IT, engineering, and regulatory teams.
5. Lead in FDA, QSR, and ISO13485 requirements promoting awareness of best industry practices and making appropriate decisions.
6. Identify and implement opportunities for improvement and implement under own initiative.
7. Maintain proactive approach to developing quality systems to meet changing business needs.
8. Ensure that in-house or external quality issues are effectively prioritized and acted upon in a timely manner.
9. Perform supplier quality audits and management of supplier corrective actions.
10. Implement mechanisms to monitor and identify supplier non-conformance trends based on risk.
11. Track supplier quality performance measurements for suppliers and participate in supplier performance reviews.
12. Completion and approval of supplier evaluations and monitoring when required.
13. Manage continuous improvement activities focusing on supplier quality.
14. Review and support supplier change notifications.
15. Review and approval of raw materials first part approval and supplier process validations.
16. Maintaining supplier quality documentation in conjunction with purchasing.
17. Liaise with quality control by providing quality engineering support to incoming quality control in-process and final quality control for raw material issues.
18. Provide input and support to the corrective and preventive action program CAPAs and the non-conforming product process.
19. Support of the internal audit supplier audit and regulatory audit programmes.
20. Completion of risk assessments of suppliers non-conforming materials and CAPAs.
21. Provide meaningful quality measurement while ensuring that in-house or external quality issues are effectively prioritised and acted upon in a timely manner.
22. Designee to the quality engineering team lead.
23. Ensure that Cook Medical Code of Conduct is considered in all business matters carried out on Cook's behalf.
24. Third Level qualification in Science Engineering or a relevant technical discipline.
25. Knowledge of relevant ISO EU FDA medical device standards regulations is required.
26. Qualified Lead Auditor preferably within the Medical Device Industry desirable.