Job Description
If you are looking for a company with a global reach that can offer you excellent career opportunities and personal development along with a local collaborative team then click below
This is a brilliant opportunity for an individual who wants to continue their growth and development within the Operational QA area and who is looking for a chance to fully own aspects of their role while working in a supportive and nurturing environment.
A bit more about the role:
1. Supporting in the supervision of Quality Technicians and QC Inspectors.
2. Drive and implement process improvements to ensure predictable processes across all product lines.
3. Provide effective and responsive QA support to Operations.
4. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's).
5. Drive and implement plant wide quality system improvements.
6. Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
7. Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
8. Approval of change requests for product, process and quality system changes.
9. Customer complaints: analysis of returns, approval of analysis reports and analysis of complaint trends.
10. Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
11. Compilation of required Regulatory documentation (E.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
12. MRB: Review of MRB trends and identification of appropriate corrective actions when required.
13. Perform internal quality audits.
14. Support the implementation of Lean Manufacturing across the site.
15. Transfer and implement product and processes from development or from another manufacturing facility.
Background, Education & Experience:
16. 2-5 years' experience in Manufacturing or Quality in a highly regulated environment. Previous medical device experience is preferred but open to other regulated industries depending on background.
17. Level 8 qualification in Engineering or related technical/Quality discipline.
18. Demonstrated ability to work with cross functional organisations in a dynamic manufacturing environment to solve problems
19. Ability to rapidly learn and use new applications
20. Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
21. Experience in problem solving and process improvement methodologies.
22. Process Validation, Risk Management, CAPA experience.
If you would like a confidential discussion about this role or other opportunities then get in touch with Kellie today on 021 2300 300 or on the below email
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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