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Senior Manufacturing Engineer

Company: Qapel Medical
Location: Sonoma
Posted on: November 18, 2021

Job Description:

Job Description You will contribute to the design, development, and manufacturability of Qapels innovative and fast-growing line of neurovascular/ vascular products. Our strategic advantage is our technology, time to market and people. You will be joining a high-performance team that consistently brings winning products the market. We are proud of our customer focused reputation we have earned from our customers and are looking for energetic motivated individuals to join our rapidly growing team. This role is multifaceted and varied; it will require you to have technical knowledge for assigned products so that you will be able to assure the design will meet customer and regulatory needs. You will head up the design transfer to manufacturing to assure the product can be manufactured and is cost effective/ within budget. We will rely on your design, development, verification, and validation testing expertise to contribute to keep the team on schedule as schedules are tight. POSITION RESPONSIBILITIES AND AUTHORITIES: Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment /fixtures per Quality system requirements. Ability to set up and run product testing and protocols in accordance with project plans. Design, specify, assemble and validate manufacturing equipment and processes. Identify and support the qualification of suppliers for materials needed for products. Ensure product documentation is in accordance with the Quality Management System requirements. Provide manufacturing engineering expertise in the daily operation and maintenance manufacturing processes and related business continuity needs in production. Troubleshoot manufacturing processes and equipment. Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of corrective actions (CAPAs). Work with R&D and Production personnel to manufacture product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer. Lead engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies, as required. Support the Quality System and Quality Policy. Be compliant with Quality System procedures and requirements, including regulatory requirements, and training requirements. Initiate corrective actions regarding concerns involving product quality as needed. Other duties as assigned

Keywords: Qapel Medical, Vallejo , Senior Manufacturing Engineer, Engineering , Sonoma, California

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