QC Inspection

                                            QC Inspector

Job Summary: The QC Inspector is responsible for performing in‑process, incoming, and final inspections of medical‑device components and finished products to ensure compliance with FDA 21 CFR Part 820, ISO 13485, internal specifications, and customer requirements. This role ensures that only conforming product moves forward in the manufacturing process and that all inspection activities are fully documented for audit readiness.

Essential Functions:

• Performs incoming, in‑process, and final inspections using visual, dimensional, and functional test methods.
• Conducts functional and mechanical testing of components and finished devices.
• Documents inspection results with accuracy and clarity, ensuring traceability.
• Verify product against engineering drawings, specifications, work instructions, and sampling plans.
• Conduct first article inspections (FAI) and complete associated documentation.
• Use measurement tools such as calipers, micrometers, height gauges, pin gauges, optical comparators, and digital inspection systems.
• Inspect labeling, packaging, and UDI information for accuracy and compliance.
• Document inspection results in Device History Records (DHRs) and electronic quality systems with complete accuracy.
• Identify, document, and segregate nonconforming material; initiate NCRs and support root‑cause investigations.
• Work closely with production, engineering, and quality teams to resolve quality issues.
• Maintain compliance with GMP, GDP, and cleanroom/controlled‑environment requirements.
• Participate in internal audits, calibration verification, and continuous‑improvement activities.
• Support validation activities (IQ/OQ/PQ) by performing documented inspections as required.

Qualifications:

• High school diploma or equivalent; technical certificate or associate degree preferred.
• 1–3 years of QC inspection experience, ideally in medical devices, electronics, or other regulated manufacturing.
• Ability to read and interpret engineering drawings, and technical specifications.
• Proficiency with basic and advanced inspection tools.
• Excellent attention to detail, recordkeeping accuracy, and communication skills. 

• Ability to work independently and make sound decisions based on objective criteria.

Preferred but not required Qualifications:

• Familiarity with statistical sampling plans (ANSI/ASQ Z1.4).
• Experience in cleanroom environments.
• Prior experience with laser marking, bonding, polishing, or other precision processes is a plus.

Competencies:

• Strong problem‑solving and critical‑thinking skills
• High attention to detail and documentation accuracy
• Ability to work cross‑functionally in a fast‑paced environment
• Commitment to patient safety and product quality
• Continuous improvement mindset

Physical and Work Environment Requirements:

• Ability to sit or stand for extended periods.
• Manual dexterity for handling small components.
• Work in cleanroom or controlled‑environment areas as required.
• Occasional travel for supplier audits or training
• Ability to lift up to 40 lbs

Travel & Benefits

• Travel is approximately 5% with international overnight stays required
• We offer a competitive base salary and benefits.