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.
• 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.

Last updated : 2024-04-23