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.