Senior Quality Engineer

This is a contract to hire position for a senior level quality engineer. This successful candidate will be posess the following desirables attributes. If you would be interested please send resumes ASAP.

- Engineering degree
-experience with plastics or inejction molding or implantables
-minimum of ten years of experience with Quality Engineering with a majority in devices
-problem solving skills
-stats, statistical applications/ SPC

v Represent Quality in product development teams/projects. Develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to release.

v Coordinate with the development of essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, product specifications, risk analysis, failure mode and effects analysis, fault tree analysis, design verification / validation, design reviews, phase reviews, and product release authorization for distribution of product.

v Work closely with business functions and project teams to develop appropriate verifications (DVT), validations (software, process), and qualifications (subcontractors, system and subsystems), for both new design and changes to released product.

v Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.

v Review & approve product verification and validation plans and reports.

v Participate in CCB to review and approve engineering change requests.

v Participate in Material Review Board (MRB) to review & disposition nonconformities and to coordinate & supplier corrective actions.

v Work with Manufacturing to direct, coordinate & monitor the production processes that are in compliance to FDA QSR,ISO13485 and other applicable regulatory requirements (JPAL,Canada, etc.); and to ensure that safe and effective products are produced.

v Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp,SPC, DOE, process data analysis, and DMAIC.

v Participate in complaint investigations and failure analysis of returned products; document findings and provide reports and analysis toCAPAbodies (QIT &CIT). Compile & institute quality metrics to trend, recommend and implement corrective action and appropriate follow-up when necessary.

v Perform other duties as assigned.

To find out more about Real Staffing please visit www.realstaffing.com