Job Description

**JOB TITLE: **Quality Inspector with CMM experience

**REPORTS TO: **Quality Engineer

**Pay Range: **$25 - $30 based on education and experience

Hours: 6:30 am – 3:00 pm

Temp to Hire

**SUMMARY: **This position works in support of the company's Quality Assurance Department. The scope of this position includes:

This role involves performing various inspections, including receiving, programming, first article inspections. Experience with CMM and Optical Comparator are required.

Demonstrating technical ability in the Receiving Inspection Department and assisting with the development of cross-functional training programs.

The Quality Control Inspector performs complex receiving, in-process, and final inspections of medical device components and assemblies in accordance with applicable regulatory, quality system, and company requirements. This position independently evaluates product conformance using advanced inspection techniques and equipment, including Coordinate Measuring Machines (CMM), supports nonconformance activities, mentors’ inspectors, and contributes to continuous improvement initiatives that support product quality and regulatory compliance.

**ESSENTIAL DUTIES AND RESPONSIBILITIES include **the following. Other duties may be assigned.

1. Inspect, test, examine, and measure raw materials, components, subassemblies, final assemblies, and associated documentation.
2. Perform visual, dimensional, and functional inspection of more complex components and/or finished medical device products using a wide variety of tools and equipment such as calipers, micrometers, depth gauges, CMM, or optical competitor, etc. to ensure conformance with design specifications and drawings - working at a level of greater independence with a higher level of productivity.
3. Interpret engineering drawings, specifications, tolerances, and inspection requirements; use hand tools and test fixtures; and train other inspectors in approved inspection methods.
4. Assists Quality Assurance Engineering, Purchasing, and Production with day-to-day receiving inspection activities.
5. Develops, leads, and participates in Quality Department continuous improvement projects.
6. Collaborates effectively with internal customers, including Production, Planning, Purchasing, Engineering, and Quality Assurance.
7. Performs all duties and assignments in a timely and accurate manner, in compliance with all quality system, GMP, and company policies.
8. Verifies the current calibration status and suitability of inspection and test equipment before use and reports any out-of-tolerance or damaged equipment in accordance with established procedures.
9. Applies approved sampling plans and acceptance criteria, including applicable AQL-based sampling requirements, in accordance with controlled procedures.
10. Identifies, segregates, and documents nonconforming material and product; initiates or supports nonconformance records and Material Review Board (MRB) activities as assigned.
11. Maintains complete, accurate, legible, and traceable inspection records in accordance with Good Documentation Practices and applicable record-retention requirements.
12. Supports Quality Engineering, Supplier Quality, and Purchasing by providing inspection data, identifying recurring supplier defects, and assisting with supplier corrective action activities as assigned.
13. Reviews and trends inspection results to identify recurring defects and opportunities for risk reduction, defect prevention, and process improvement.
14. Participates in developing and conducting training for the Quality Control department and provides technical guidance to QC Inspector I personnel.

**EDUCATION and/or EXPERIENCE: **Equivalent combination of education and experience from the below list will meet the requirements for this position:

• High school diploma or GED and a minimum of 3-5 years of related inspection experience in an FDA- and ISO-regulated industry; experience in electromechanical medical device manufacturing is preferred.
• Quality Inspector Certificate a plus
• Proficient knowledge of component testing, receiving inspection, in-process inspection, finished-product inspection, and accurate quality-record completion
• Working knowledge of inspection equipment, including calipers, micrometers, pin gauges, optical comparators, and Coordinate Measuring Machines (CMM)
• Working knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA Quality System Regulation requirements under 21 CFR Part 820, and ISO 13485

Email resume: [email protected]

Call/Email: (714) 399-0951

You should be proficient in:

• FDA Regulations
• AS9100 Quality Systems
• Good Manufacturing Practices (GMP)
• AS9100 Experience

Machines & technologies you'll use:

• Optical Comparator
• Coordinate Measuring Machine (CMM)
• Measurement Gauges
• Calipers and Micrometers