Quality Assurance Technician

Millenniumsoft staffing services
Zelienople, United States of America
1 month ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English

Job location

Zelienople, United States of America

Tech stack

Microsoft Word
Microsoft Excel
Failure Mode Effects Analysis

Job description

  • 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.

  • Accurately document non-conformity when applicable with clear characterization.

  • Process service records for BD Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness, and correctness.

  • Daytime hours.

  • 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.

  • 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.

  • Accept or Reject products as defined in the inspection instruction/ checklist.

  • 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

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