Quality Assurance/Quality Control Inspector - Entry Level

MillenniumSoft Inc; Zelienople (Butler County); On-site; USD 28,000 - 34,000; Part time

Job summary

MillenniumSoft Inc is seeking an entry-level Quality Assurance/Quality Control Inspector to support routine inspection and QA documentation for a medical devices client in Zelienople, PA. The role focuses on applying GMP/QSR standards and using basic measurement tools to ensure parts meet requirements.

You will review records, perform basic inspections, and help maintain compliance with FDA and ISO 13485 requirements during a 5-month contract with a 40-hour work week.

Qualifications

• Associate degree or equivalent experience in a technical field.
• Working knowledge of Microsoft Office Suite (Excel, Word).
• Operate to FDA 21 CFR Part 820 and ISO 13485.
• Basic understanding of GMP and QSR.
• Familiar with a variety of measurement equipment.

Responsibilities

• Inspect incoming service material and perform quality reviews per instructions.
• Utilize basic measurement tools (micrometers, calipers, height gauges, thread gauges) to inspect parts.
• Document non-conformities with clear characterization and proper paperwork.
• Support root-cause analysis and dispositions for failed parts as needed.
• Review service records for accuracy and completeness to ensure quality compliance.

Skills

Communication skills

Teamwork

Attention to detail

Education

Associate degree in a technical field

Tools

Microsoft Office Suite

Excel

Word

Job description

Position : Quality Assurance/Quality Control Inspectro - Entry Level

Location : Zelienople, PA

Duration : 5 Month

Total Hours/week : 40.00

Pay rate : $20-25/hr

Shift : 1st Shift

Client : Medical Devices Company

Job Category : Quality

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

• 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 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