2nd Shift Quality Inspector II

Marquee Staffing; Irvine (CA); On-site; USD 30,000 - 42,000; Full time

Job summary

Marquee Staffing is seeking a QC Inspector II to perform in-process and final inspections of medical device insulin pump subassemblies and finished products. The role requires careful review of records, adherence to GDP/GMP, and precise documentation. Shift is 2nd, with a pay rate of $26/hour.

Ideal candidates have 2+ years in medical device QC, experience with AQL sampling, and strong attention to detail in fast-paced environments. This is a full-time, on-site role in Irvine, CA.

Qualifications

• 2+ years of in-process and final QC inspection experience in medical devices.
• Experience with visual inspection, record review, and documenting inspection outcomes.
• Ability to interpret procedures, drawings, specifications, and acceptance criteria.

Responsibilities

• Perform in-process and final inspections following approved procedures, drawings, specs, and acceptance criteria.
• Review manufacturing routers, lot history records, and electronic device history records for completeness/accuracy (GDP compliance).
• Conduct visual inspection for damage and assembly defects.
• Verify software versions and device configuration using approved electronic applications/records.
• Verify labeling and packaging (accuracy, legibility, barcode/QR content, packaging condition, required contents).

Skills

In-process QC inspection

Final QC inspection

AQL sampling

GDP/GMP

Device history records

Education

High school diploma

Tools

ERP systems

Electronic record systems

Job description

Overview

The QC Inspector II (In-Process and Final QC) independently performs in-process and final inspections of medical device insulin pump subassemblies and finished products to verify conformance to approved requirements (procedures, drawings, specifications, and acceptance criteria). $26/hr 2nd Shift 3:00pm - 11:30pm Monday - Friday

Essential Duties & Responsibilities

• Perform in-process and final inspections following approved procedures, drawings, specs, and acceptance criteria
• Review manufacturing routers, lot history records, and electronic device history records for completeness/accuracy (GDP compliance)
• Conduct visual inspection for damage and assembly defects
• Verify software versions and device configuration using approved electronic applications/records
• Verify labeling and packaging (accuracy, legibility, barcode/QR content, packaging condition, required contents)
• Review manufacturing/quality test results and sterilization records for acceptable results, traceability, and release requirements
• Collect, label, and document retain samples per procedure
• Apply AQL sampling plans to select samples and determine lot acceptance/rejection
• Document inspection results, approvals, and nonconformances in quality/ERP systems; maintain controlled logs/records
• Complete authorized inspection and product release activities (update status and apply release identification)
• Identify and document nonconforming product, ensure material is held/quarantined, and notify Quality/Supervisor promptly
• Perform work in compliance with GDP/GMP, supporting ISO 13485 and FDA QMSR requirements

Required Education & Experience

• High school diploma (or equivalent)
• 2+ years of in-process and final QC inspection experience in the medical device industry
• Experience with visual inspection, record review, and documenting inspection outcomes
• Ability to interpret procedures, drawings, specifications, and acceptance criteria
• Experience applying AQL / acceptance sampling plans
• Working knowledge of GDP, GMP, and traceability
• Comfortable with computers/tablets/electronic record systems
• Strong attention to detail, organization, and communication skills; able to work independently and manage priorities

Preferred Qualifications

• Experience working in ISO Class 8 cleanrooms
• Familiarity with ISO 13485 and FDA QMSR

Work Environment & Physical Requirements

• Work performed across manufacturing/inspection/office areas, including controlled environments/cleanrooms as applicable
• Must follow gowning/PPE and safety requirements
• Ability to sit/stand for extended periods, perform detailed visual inspection, and handle small components/packaging
• Manual dexterity and repetitive hand motion; ability to use computers/tablets