Job Description
A new and exciting opportunity for a Validation Engineer has come up with one of Cork's leading Medical Device companies on a 12 month hourly rate contract.
In this role, you will support quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
You will need to have 4 years experience in a Quality or Validation role with knowledge of GMP regulations.
Responsibilities:
1. Collaborating with QA, cross functional and suppliers' teams to deal with quality issues
2. Executing Commissioning, Qualification, and Validation protocols efficiently while working in a multidisciplinary team
3. Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
4. Manage internal and supplier non-conformances
5. Manage identified internal CAPAs, RCA's and investigations
6. Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required
7. Development and Improve internal manufacturing processes for company products
8. Perform critical assessment of internal and supplier change management activities
9. Carry out PPAP tasks for supplier changes
10. Participate and lead in the creation of new or modified procedures
11. Maintain KPIs for process and product quality
12. Execute and analyze manufacturing related complaints and product field actions
13. Collaborate with stakeholders to identify and execute opportunities
Required Qualification & Experience
14. Level 8 Degree in a relevant field
15. 4 years experience in Quality and Validation
16. Experience with regulatory agencies (FDA, MoH, TUV, etc.)
17. Familiarity with ISO 13485, GDP, GMP regulations
18. Understanding of EU, US and other Medical Device Regulations
19. Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
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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