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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Quality - Tech Transfer Specialist


Reference:SMC00034791 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Engineer, EHS Specialist

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.

Purpose

Reporting to the QA Technical Leader the Technology Transfer Engineer shall lead from a Quality Technology Transfer Engineering perspective.

Responsibilities

• 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