Job Title:
Technology Transfer Engineer
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Purpose:
The Technology Transfer Engineer will lead from a Quality Technology Transfer Engineering perspective, reporting to the QA Technical Leader.
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Responsibilities:
* Document and maintain in good order all relevant Quality assurance sections of devices.
* Provide QA input for URS for new technology/equipment.
* Liaise with R & D to ensure CTQs are agreed and documented for all NPD.
* Lead Design for Inspection activities for all NPD to ensure the latest technology is available to reduce human factors.
* Lead QA input in Design for Manufacture activities on site.
* Ensure correct use of statistical QA methods in the production environment and provide technical resource for the production team on relevant IQ/OQ/PQ protocol issues.
* Ensure compliance with all documented Quality systems, as per SEP 180 i.e. FDA QSR's and ISO 13485/9001 requirements 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 processes enabling reduction in scrap and reprocessing.
* Monitor and establish scrap and reprocessing rates for all NPD. Report on these issues, and identify trends and appropriate corrective actions.
* Review and approve product, gauge, tooling, and fixturing drawings.
* Operate within the company's standard operating procedures and review, maintain, and create appropriate procedures for the sphere of activity.
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Qualifications and 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.
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Estimated Salary:
$120,000 - $150,000 per annum based on industry standards in Cork, Ireland.