Technology Transfer Engineer
Posted on Jun 10, 2019 by CV-Library
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 the clients 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 onsite 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.
Desired Experience and Background of the successful candidate
* 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.
* Demonstrate standards of leadership – Managing complexity
* Interdependent Partnership
* Customer / Market Place Focus
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment
£293 - £335 Daily
£42k - £50.4k Annual
£29.4k - £37.8k Annual