Regional Quality Assurance - Medical Devices
An exciting new opportunity has become available for a Quality Assurance Manager. Candidates will be require to have strong documentation skills and experience within a highly regulated sector such in a pharma, medical device or aerospace industry will be beneficial.
Quality Assurance Managers Responsibilities;
- 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 Document Control
- Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software.
- Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed
- 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.
- Be responsible for the introduction and 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, FDA QSR's and ISO 9001 requirements during day to day and assigned audit/CAPA activities
- Develop and implement Quality planning as directed to demonstrate and realise a continual improvement in product and service quality
- Monitor and establish reject and rework rates as directed. Report on these issues, and identify trends and appropriate corrective actions
Quality Assurance Requirements;
- HNC or Engineering degree
- 5 years engineering experience, ideally have served an engineering apprenticeship
- Must have an engineering background in manufacturing, with a proven ability to interpret and create engineering specifications and procedures
- Should have QA Engineering experience, and awareness of quality systems and techniques such as SPC, AQL, FMEA,ISO9001 and FDA QSR's and CGMP's
- Should have CMM operating and programming experience - Gauge design and a good understanding of geometric tolerancing would be a distinct advantage
- Must be PC literate, and familiar with MS Office applications.
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to contact me on 0207 758 7322
To find out more about Real please visit www.realstaffing.com