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.
Reporting to the QA Technical Leader the Technology Transfer Engineer shall lead from a Quality Technology Transfer Engineering perspective.
• Document and maintain in good order all relevant Quality assurance sections of Device
• Provide QA input for URS for new technology / equipment.
• Liase with R & D to ensure CTQs are agreed and documented for all NPD.
• Lead Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.
• Lead QA input in Design for Manufacture activities on site.
• Ensure correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
• Ensure compliance with all Documented Quality system, as per SEP 180 i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
• Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
• Assist in problem solving in established production process enabling reduction in scrap and reprocessing.
• Monitor and establish scrap and reprocessing rates as for all NPD. Report on these issues, and identify trends and appropriate corrective actions.
• Review and approve product, gauge, tooling and fixturing drawings.
• To operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for sphere of activity.
Qualifications & Experience
• A degree level or similar qualification in mechanical or industrial engineering.
• Proven ability to successfully introduce new product development in the Medical Device Industry.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480