QA Technician

Fremont, CA 94536

Posted: 10/24/2019 Industry: Industrial Job Number: 9270

Job Description


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.

RESPONSIBILITES:

  • 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



  • Receive components and assemblies



  • Review POs and assign traceability as needed



  • Failure analysis of complaint units per established procedure



  • Verification activities as needed under an engineer's direction





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



EDUCATION/EXPERIENCE:

High school, AA or equivalent experience required. 5 years' experience in a medical device company and/or at least 5 years of quality control experience in the medical devices industry

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