Quality Assurance Technician

Position : Quality Assurance Technician

Location : Zelienople, PA

Duration : 6 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Professional

Level of Experience : Entry - Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

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 (Micrometres, callipers, 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