Address
Form of work 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.
Requirements:
- 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 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.
