Our Cork based Medical Device client are currently seeking a number of Technology Transfer Engineers. You 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.
• 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.
• 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.
• Maintain a good level of house keeping 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 and Experience:
- A degree level or similar qualification in mechanical or industrial engineering.
- 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 additional information, or to submit your CV get in touch with [email protected]