Overview
Overview The QC Inspector II (Receiving Inspection) independently performs and documents receiving inspections of incoming components, materials, and assemblies to verify conformance to approved requirements. Applicants must have experience with metrology equipment for receiving inspection of materials (calipers, micrometers) Keyence experience highy desired $31.50/hr 2nd Shift 3:00pm - 11:30pm Monday - Friday
Essential Duties & Responsibilities
- Perform visual and dimensional inspections of incoming components/materials/assemblies (including contract-manufactured product) against approved drawings, specs, and inspection plans
- Review supplier documentation (certs, packing lists, test reports) for completeness, accuracy, and conformance to purchasing/spec requirements
- Verify part numbers, revisions, quantities, lot numbers, expiration dates, and container labeling
- Apply AQL sampling plans to determine sample sizes and lot acceptance/rejection
- Use calibrated inspection tools and optical measurement systems; confirm correct programs/versions/setups prior to inspection
- Perform first article inspections and other approved custom inspections; document results and route for Quality review prior to release
- Document results in quality/ERP systems; maintain traceability, complete inspection orders, and process authorized inventory transactions
- Apply acceptance identification and transfer accepted material to designated locations
- Identify/segregate nonconforming material; document issues, notify Quality, and provide supporting evidence
- Partner with Purchasing, Supplier Quality, Engineering, and Warehouse teams to resolve discrepancies
- Maintain inspection area organization and controls (line clearance, calibration verification, cleaning and ESD precautions)
- 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 receiving or dimensional inspection experience in the medical device industry
- Ability to interpret engineering drawings, dimensional tolerances, specifications, and inspection criteria
- Hands-on experience with tools such as calipers, micrometers, pin gauges, indicators, microscopes
- Experience using AQL / acceptance sampling plans
- Working knowledge of GDP, GMP, traceability, and nonconforming material controls
- Comfortable with computers and electronic record systems
- Strong attention to detail and communication; able to work independently and manage priorities
Preferred Qualifications
- Hands-on experience with Keyence optical measurement systems (running established programs + producing reports)
- First article inspection experience
- Knowledge of GD&T
- Familiarity with ISO 13485 and FDA QMSR
Work Environment & Physical Requirements
- Work performed across receiving/inspection/warehouse/office areas
- Must follow PPE, safety, and material handling requirements
- Ability to sit/stand for extended periods and perform detailed visual inspection
- Manual dexterity for small components and precision measurement tools; repetitive hand motion
- Ability to move materials/components between inspection and staging areas