Tech 2, Quality Assurance

3 weeks ago

Zelienople, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities Ensure compliance of purchased parts delivered to Service. Utilize basic measurement tools to inspect parts (Micrometers, calipers, height gage, thread gage, scales, pin gages, etc.) Perform inspections, checks, and follow sampling procedures according to the applicable instructions on products having been delivered by suppliers before their use in production. Process all appropriate paperwork for inspection operations. Accept or Reject products as defined in the inspection instruction/ checklist. Accurately document non-conformity when applicable with clear characterization Material Review Support – May be asked to support investigation of electrical/electronic or mechanical parts to determine root causes of failures and to assist with dispositions of failed parts. Process service records for Client Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness, and correctness. Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations. Perform other duties as assigned.

Responsibilities:

Excellent communication and team skills as well as a keen attention to detail. Associate degree in a related technical field or equivalent experience. Working knowledge of Microsoft Office Suite, Excel, Word, etc. Operate to the requirements of FDA CFR Part and ISO . Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR). Familiar with a variety of measurement equipment.

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