QC Inspector

Aviso, LLC • Fremont, CA

15h • Onsite

About The Position

The QC Inspector performs 100% in-process and final visual, dimensional, and optical inspection of critical sub-assemblies in a medical device manufacturing environment. Every unit must be evaluated, verified, and signed off. The role has two immediate openings on 2nd shift and requires high autonomy and rigorous inspection standards.

Inspectors spend most or all of the shift in a cleanroom, working at dedicated inspection cells with sit/stand ergonomic benches. Inspection includes microscope examination of welds, adhesive fill, watertight seals, jewel orifice seating, and foreign particulate; dimensional verification against engineering specifications; and optical testing after a mandatory 12-hour adhesive cure dwell period.

The inspector may reject non-conforming parts, apply physical quarantine tags, and place items in designated red scrap or rework bins. The role also requires manually completing Device History Records (DHR) and batch records in real time, including dates, times, counts, and signatures. Records are audited after the shift by external Quality Assurance.

Requirements

• At least 5 years of Quality Control experience in medical device manufacturing, in an ISO 13485 / FDA cGMP environment.
• Stamina to inspect micro-components through microscope eyepieces for up to 6–8 hours daily.
• Proficiency with calipers, micrometers, height/drop gauges, and custom mechanical fixtures.
• Meticulous documentation discipline emphasizing accuracy, traceability, and compliant error correction.
• Ability to work with high autonomy and rigorous standards on 2nd shift.

Responsibilities

• Perform 100% in-process and final visual, dimensional, and optical inspection of critical sub-assemblies.
• Inspect components under binocular and digital monitor microscopes for weld bead integrity, adhesive fill, void-free watertight sealing, jewel orifice seating, and foreign particulate.
• Verify sub-assemblies against engineering specifications using dimensional metrology tools and go/no-go fixtures.
• Perform post-cure optical testing of light transmission, fiber-optic alignment, and camera image clarity after the 12-hour adhesive cure dwell period.
• Reject non-conforming parts, apply physical quarantine tags, and place items into designated scrap or rework bins.
• Complete Device History Records and batch records manually and in real time, recording dates, times, counts, and signatures.
• Maintain documentation accuracy, traceability, and compliant error correction practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed