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QC Technician III

Company: SeaSpine
Location: Irvine
Posted on: June 6, 2021

Job Description:

Our QC Technician Ill carries out inspections and testing at various stages of production of the product - from raw materials, sub-assemblies, and final assemblies to assure product quality and conformance to specifications and procedural requirements. You'll also analyze problems, determine problem-solving techniques, and exercise judgment in selecting appropriate solutions.

Essential Resposnibilities:

  • Interpret engineering drawings, schematic diagrams to complete incoming, in-process and final inspections
  • Use a wide assortment of QC inspection instruments to assure components and devices are manufactured and functioning according to specification
  • Record test data and interpret its pass/fail status
  • Perform and documents all QA inspection and testing activities to assure conformance to specifications
  • Perform label inspections
  • Audit various manufacturing processes to assure compliance and product segregation
  • Monitor quality product in all stages of manufacturing and packaging process to determine proper sampling and variations in the process
  • Review donor records for compliance
  • Compile and reviews device history records to assure compliance and releases products to Finished Goods
  • Initiate non-conformance reports (NCRs) and follows-up to final disposition of nonconforming materials
  • Assist in developing and implementing Corrective and Preventive Actions (CAPA's) using known problem-solving techniques. Assists in developing and implementing Document Change Orders (DCO's)
  • Redline/revise specifications as needed, to assure QSR compliance
  • Train other QC Technicians on new or revised procedures
  • Investigate and report complaints on existing products as directed by QA Management
  • Complete and process quality reports and entering into the computerized quality reporting database

Required Qualifications:

  • High School Diploma or equivalent
  • 7+ years related experience.
  • Knowledge of GMPs (QSR) and/or ISO 9001 and ISO 13485 regulations, Medical Device manufacturing experience, Cleanroom manufacturing experience
  • Experience with usage of common inspection tools (e.g., rulers, calipers): read blueprint drawings.
  • Experience with usage of inspection techniques and knowledge of statistical sampling plans. Strong attention to detail. Ability to balance and prioritize inspections and job responsibilities to support production. Focused with a strong sense of urgency
  • Advanced proficiency with Microsoft Office, specifically Word and Excel
  • Strong analytical, mathematical, and problem-solving abilities, with a focus on meeting customer needs
  • Excellent communication skills with a strong ability to write business reports and correspondence, as well as the ability to speak effectively before groups of peers, leadership, and customers
  • Critical thinker with strong attention to detail and ability to problem-solve and establish solutions in a high-growth and fast-pace environment

Preferred Qualifications:

  • Technical College
  • Associate's Degree
  • Bachelor's Degree
  • ASQ Certifications such as but not limited to CQI or CQT

Keywords: SeaSpine, Irvine , QC Technician III, Other , Irvine, California

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