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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.

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