Quality Assurance Inspection Technician

Qualifications

• 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

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 BD 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