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