:
1. Performance management and development of the Quality Engineering (QE)Team
2. Responsible for the technical complaint process and providing technical support to both internal and external Customers when required
3. Management of process and equipment performance qualifications
4. QE Lead for global harmonisation projects and major equipment, process and facility changes
5. Management of the Investigation process associated with Customer complaints and internal investigations.
6. Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
7. Provide effective oversight of the execution of the Quality Plan, Risk Management activities and of all design related activities during the product/system lifecycles, including validation master plan
8. Work with the global Quality Engineering, Engineering and Operations group to provide technical support for products and processes
9. Execute & maintain risk assessments related to quality engineering processes
10. QE process subject matter expert for external audits/visits
11. Lead Auditor for internal and subject matter expert for third party audits when required.
12. Develop and implement strategic plans to drive quality improvements and meet quality, health and safety, PPI and operational goals
13. Ensure validation protocols and process procedures meet FDA 21CFR820 and ISO 13485 requirements
14. Management of QE budget and AOP planning
15. Deputy for the Site Senior Quality Manager
Minimum Requirements/Qualifications:
16. Management/Leadership experience, self-motivator and drive to develop others
17. Degree in a Scientific or Engineering based subject or significant experience within the Pharmaceutical/Biotech industry
18. Strong knowledge of FDA 21CFR820 and ISO13485
19. Experience working in a Quality or Engineering role and sound knowledge of operational processes
20. Project management experience
21. Qualified Lead Auditor preferably to ISO13485 standards
22. Exceptional problem solving and report writing skills
23. Self-assertive and able to drive new initiatives
24. Excellent communication and writing skills
25. Experience related to continuous improvement/lean processes
26. Ability to make rational, objective and appropriate decisions relating to company & department requirements.
27. Communicate recommendations and decisions across the organization.
28. Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements
29. Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
30. Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
31. Ability to analyze and process data and draw appropriate conclusions.
32. Experience prioritizing conflicting demands
33. Excellent interpersonal, organizational, and influencing skills
34. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems