Quality Assurance Technician
Roles & 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 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.
Experience Required
Working knowledge of Microsoft Office Suite, Excel, Word, etc.
Skills & Certifications
- Excellent communication and team skills as well as a keen attention to detail.
Eligibilities & qualifications
- Associate Degree in a related technical field or equivalent experience
- Operate to the requirements of FDA 21 CFR Part 820 and ISO 13485
- Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)
- Familiar with a variety of measurement equipment.
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