CMM Programmer - Medical Devices

PE Global
14 Oct 2016
22 Oct 2016
Position Responsibilities Essential Functions: 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 (Goods In Check procedures) Program Co-ordinate Measuring Machines (Mitutoyo Cosmos Software) and carry out necessary program verification activities. Develop / improve inspection strategies for manufactured products. Document and maintain in good order all relevant Quality assurance sections of Device History File (DHR) and Device Master Record (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. Ensure correct implementation as per standard validation procedures. 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. Produce automated verification solutions – train/certify personnel as required 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. Support adequate product specific microbial assurance activities via appropriate liaison with Microbiologist and product packaging group. 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. Experience: Skills and Abilities: 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. 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. This job was originally posted as

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