Job Description
Pay Range $15.50hr - $20.50hr
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 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.
- 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.