QC Inspector
- Fremont, CA, United States
$30.8 USD / hour
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Job details
- Pay
- $30.8 USD / hour
- Experience
- ▪ Experience: 5+ years in Quality Control within medical device manufacturing (ISO 13485 / FDA cGMP environment).
- Posting language
- English
- Posted
Original job description
Operational Focus: 100% In-Process & Final Visual, Dimensional & Optical Inspection
- Supervision & Department Scope: Two (2) immediate openings on 2nd Shift. Daytime department has ~22 inspectors; swing shift requires high autonomy and rigorous standards.
- Cleanroom Duty Cycle: Inspectors spend the majority to the entirety of the shift inside the cleanroom across dedicated inspection cells with sit/stand ergonomic benches.
- Inspection Mandate: 100% inspection across all critical sub-assemblies. Every single unit must be evaluated, verified, and signed off.
Core Inspection Methods & Technical Tools
- Microscope Visual Inspection: High-magnification inspection under binocular microscopes and digital monitor microscopes to evaluate weld bead integrity, adhesive fill, void-free watertight sealing, jewel orifice seating, and foreign particulate.
- Dimensional Metrology & Go/No-Go Fixtures: Verifying sub-assemblies against engineering specifications using drop indicators, dial calipers, micrometers, and precision go/no-go plug and ring gauges.
- Post-Cure Optical Testing: Validating light transmission, fiber-optic alignment, and camera image clarity following the mandatory 12-hour adhesive cure dwell period.
- Quarantine & Defect Containment: Full authority to reject non-conforming parts, apply physical quarantine tags, and place items into designated red scrap/rework bins.
- Good Documentation Practices (GDP) & DHR: 100% manual pen-and-paper Device History Records (DHR) and batch records. Every inspection step requires real-time date/time stamps, counts, and signatures. Audited post-shift by external Quality Assurance.
Ideal Candidate Profile & Screening Criteria
- Experience: 5+ years in Quality Control within medical device manufacturing (ISO 13485 / FDA cGMP environment).
- Microscope Endurance: Proven stamina to inspect micro-components under microscope eyepieces for up to 6–8 hours daily.
- Tool Competency: Demonstrated proficiency with calipers, micrometers, height/drop gauges, and custom mechanical fixtures.
- GDP Rigor: Meticulous documentation discipline with an emphasis on accuracy, traceability, and error-correction compliance.