Our client, a medical device company in Cork is currently looking to recruit a Technology Transfer Engineer
for their site.
Reporting to the QA Technical Leader the Technology Transfer Engineer shall lead from a Quality Technology Transfer Engineering perspective.
The job holder will lead the QA element of process / technological improvements and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
• All World Wide facility Quality, Operational and R&D.
• Vendor management personnel.
- Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on-site production and purchased for resale goods.
- Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed by Data Management.
- Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
- Provide QA input for URS for new technology / equipment.
- Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Liaise 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.
- Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements.
- 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.
- Minimum 5 years’ experience in a quality role within a regulated industry.
- Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
- Proven experience and training in Mechanical Engineering processes.
For further information on this Technology Transfer Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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