QC Inspector

Aviso, LLC; Fremont (CA); On-site; USD 39,000 - 58,000; Full time

Job summary

Aviso, LLC seeks experienced Quality Control inspectors for 2nd shift in Fremont, CA. You will perform 100% in-process and final visual, dimensional and optical inspections in a cleanroom using microscopes, calipers and micrometers.

Candidates must have 5+ years in medical device QC (ISO 13485 / FDA cGMP) and be adept at GDP, DHR documentation, quarantine and defect containment. The role requires meticulous attention to traceability, and the ability to work with sit/stand ergonomic benches and

Qualifications

• 5+ years in Quality Control within medical device manufacturing (ISO 13485 / FDA cGMP).
• Microscope endur​ance for 6–8 hours daily.
• Proficient with calipers, micrometers, height/drop gauges and custom fixtures.
• GDP discipline with accuracy, traceability and proper documentation.

Responsibilities

• Perform 100% in-process and final visual, dimensional and optical inspections.
• Work in cleanroom cells with sit/stand benches and use precision tools.
• Maintain GDP/DHR records with real-time date/time stamps and signatures.

Skills

Microscope endurance

GDP rigor

Documentation discipline

Tools

Calipers

Micrometers

Height/Drop gauges

Custom fixtures

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.