Medical Device Quality Inspector | FAI & NPI Support

Enovis; Vista (CA); On-site; USD 52,000 - 82,000; Full time

Job summary

Enovis in Vista, CA is seeking a Quality Control Inspector to perform incoming, in-process, and final inspections and to maintain quality documentation. You will work with Quality, Manufacturing, and Operations to ensure products meet specifications and support production needs across the supply chain.

The role involves collaboration on NPI projects, documentation of test results, and adherence to ISO 13485 and FDA quality systems in a manufacturing setting.

Qualifications

• High school diploma or equivalent.
• 2-4 years quality control/inspection/manufacturing in regulated environment (medical device preferred).
• Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR and related quality regs.
• Ability to read and interpret engineering drawings, GD&T.
• Proficiency with calipers, micrometers, height gauges, comparators, pin gauges.

Responsibilities

• Perform incoming, in-process, final, and stock verification inspections per procedures.
• Support in-process inspections and manufacturing quality activities.
• Execute First Article Inspections (FAI) and support qualification activities.
• Assist with validation/verification including data collection and documentation review.
• Collaborate with Quality Engineers and cross-functional teams on NPI and product transfers.
• Coordinate NCMR activities including disposition routing.
• Maintain accurate quality records and inspection reports per QMS.

Skills

Quality control

Inspection

GD&T

Measuring tools

Documentation

Reading drawings

Root cause

ERP systems

Excel

Communication

Education

High school diploma

Tools

Oracle

SAP

NetSuite

MasterControl

ETQ

Job description

Enovis in Vista, CA is seeking a Quality Control Inspector to perform incoming, in-process, and final inspections and to maintain quality documentation. You will work with Quality, Manufacturing, and Operations to ensure products meet specifications and support production needs across the supply chain.

The role involves collaboration on NPI projects, documentation of test results, and adherence to ISO 13485 and FDA quality systems in a manufacturing setting.