We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do. The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, and systems.
1. Responsible for ensuring conformance with current equipment, process, and systems validation regulations
2. Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
3. Responsible for completing gauge R&R qualifications.
4. Participate in Worldwide equipment, process, and software development.
5. Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures.
6. Responsible for determining process inputs and factors for variation where process capability is required
7. Responsible for calculating process capability
8. Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises.
9. Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel.
10. Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
11. Responsible for validation activities for NPI’s / product transfers.
12. Responsible for Quality Engineering responsibilities of NPI’s / product transfers
13. Responsible for process and equipment risk management pFMEA / RA
14. Responsible for implementing/validating new technologies.
15. Contribute towards company procedures regarding validations.
16. Responsible for conducting periodic review activities concerning the above.
17. Ensure HSE is included on all Quality change order procedure.
18. All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
Degree level qualification in Engineering/Electronics or Equivalent.
Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
Experience in aspects of QA, validation and ISO 13485.
Six Sigma Black Belt Certified
Statistical Engineering Qualification
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480
PLEASE APPLY DIRECTLY BY CLICKING HERE
Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.
Science Recruitment | Engineering Jobs | Scientific Jobs
Pharmaceutical Jobs | Medical Device Jobs | Clinical Research Jobs | Biotechnology Jobs