Senior Quality Engineer

I have a position for a Senior Quality Engineer with a well established medical device company in the local Irvine area. In the design transfer phase, partner with Engineering and Manufacturing to ensure products are effectively and appropriately transferred to internal or contract Manufacturing. Specifically: * Plan, coordinate, and implement production process and production equipment controls. * Develop Standard Test Methods and provide training. * Lead the development of quality control procedures within the manufacturing process, with focus on the mechanical subsystems of the device. * Help communicate expectations around quality control to suppliers, and coordinate part and process approval. * Work with Manufacturing to solve in-house quality issues, review nonconforming product, and recommend disposition. In the production phase, collaborate with all functional stakeholders in order to: * Monitor product quality. * Assess and monitor process stability using SPC. * Establish process capability. * Based on monitored data, provide solutions for corrections or improvements. * Participate in the assessment of post-market surveillance feedback and implement any resulting CAPAs or necessary improvements to process controls. * Participate in in post-production risk management and ECR activities. Experience and Qualifications: * Education: Bachelor of Science degree (Mechanical, Applied Physics, etc.) or equivalent engineering degree. * At least 5 years of QA/QC experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices. * Experience working in environments compliant with ISO 13485 If you are qualified for this position please respond ASAP to be considered for an interview.

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