A Technology Transfer Quality Engineer is required by CareerWise Recruitment for a major global med device client to lead the QA function of process / technology improvements and product transfers . This is an initial 12 month contract role . Please contact Diarmuid Buckley for full details.
Role of this position
- Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products.
- 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.
- 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.
- Degree level or similar qualification in mechanical or industrial engineering.
- 3- 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.
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: firstname.lastname@example.orgCareerWise Recruitment (In Search of Excellence)