Quality Assurance/Quality Control Inspector - Entry Level

Location: Zelienople, PA • Duration: 5 months • Hours: 40/week • Pay rate: $20–25/hr • 1st shift • Contract on W2 (US citizens, GC holders, GC EAD, OPT, EAD, or CPT only)

About the role

This position conducts routine inspection and analysis of incoming service material and quality reviews of domestic and international service records. The role identifies conflicts, dependencies, and release risks to ensure compliance with Quality Assurance Standards and procedures.

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 applicable instructions on products 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.
• Support Material Review investigations of electrical/electronic or mechanical parts to determine root causes of failures and 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.

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.

Pay

$20–25 per hour

Schedule

40 hours per week, 1st shift