Work days (M F)
Work hours (7:30am 4:00pm)
Onsite Position
Job Description Summary
This position is responsible for conducting routine inspection and analysis of incoming service material and quality reviews of domestic and international service records by identifying conflicts, dependencies, and risk of release to ensure Quality Assurance Standards and procedures are met.
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 *** 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