Entry-Level QA Technician - Medical Devices

MillenniumSoft Inc; Zelienople (Butler County); On-site; USD 28,000 - 41,000; Full time

Job summary

MillenniumSoft Inc. is recruiting an Entry-Level Quality Assurance Technician for a 12-month contract in Zelienople, PA. The role focuses on inspecting incoming service materials and reviewing domestic/international service records to ensure compliance with QA standards.

You will use basic measurement tools, document findings, and support inspections per FDA 21 CFR Part 820 and ISO 13485. Strong attention to detail and teamwork are required.

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 characterisation
• 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 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

Skills

Excellent communication

Team skills

Attention to detail

Education

Associate Degree in a related technical field

Tools

Microsoft Office Suite

Excel

Word

Job description

MillenniumSoft Inc. is recruiting an Entry-Level Quality Assurance Technician for a 12-month contract in Zelienople, PA. The role focuses on inspecting incoming service materials and reviewing domestic/international service records to ensure compliance with QA standards.

You will use basic measurement tools, document findings, and support inspections per FDA 21 CFR Part 820 and ISO 13485. Strong attention to detail and teamwork are required.