Quality Assurance/Quality Control (19-00943) – CA – Fremont

Job Title: QA Technician
Responsible for inspection of components and testing/inspection of finished goods. In addition, support the QA team with verification activities, failure analysis and other technician level activities under QA managements direction. This is a second shift position. Inspection – Incoming/In-process/Finished Goods· Inspect incoming components, sub-assemblies and final assemblies per procedure and/or specifications· Verify specifications using blueprints, drawing or inspection instructions and checklists· Make pass/fail decisions on inspected goods. Maintain records of inspections· Ensure all quality issues are communicated in a timely manner· Initiate Non-conformance Material Report· Participate in Materials Review Board/Investigations Manage IQA and MRB warehouses· Provide accurate monthly cycle counts to Finance· Provide management with monthly IQA trends· Support complaint failure investigation activities when required. Support day-to-day activities such as:· Final QC support for manufacturing line· Understand inspection specifications and be able to execute on the most efficient and accurate inspection techniques· Perform first article inspections on new components, fixtures & for supplier qualifications· Provide quick turnaround on incoming parts· Support IQA traffic and prioritize efficiently to keep backlog to a minimum· Initiate NCMR paperwork and follow up with closure in a timely manner· Escalate non-conformances quickly and effectively· Suggest creative solutions to make processes more error free, repeatable and scalable· Communicate quality issues effectively to engineering in MRB meetings· Receiving and Traceability . Receive components and assemblies . Review POs and assign traceability as neededo DHR Review o Sterilization Release · Failure analysis of complaint units per established procedure · Verification activities as needed under an engineer’s direction · All other duties as assigned
Skills:· Must have a good understanding of FDA, ISO and Quality Management Systems requirements for medical devices· Must be able to understand and execute on directions· Must be detail oriented, well organized and have excellent communication skills· Must be able to accomplish objectives with minimal supervision· Must be proficient in use of measurement tools such as CMM, micrometers, calipers, height gages, etc.· Must have the ability to read and understand blueprints, drawings, component specifications and other documented specifications and procedures
Source: Job Diva – Job Listing

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