Medical Device Quality Inspector – 2nd Shift

Primo Medical Group; Bridgewater, Northern (MA, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Primo Medical Group, Inc. is a leader in medical devices and precision machined components seeking a Quality Inspector for 2nd shift. You will perform incoming, in-process, and final inspections, document results, and prepare NCMR/CDR when discrepancies arise.

You will maintain QA records, verify certifications, and assist with device history records and final release documentation, contributing to compliance with FDA QSR and ISO 13485 standards.

Qualifications

• High School diploma or equivalent with 3–5 years in manufacturing or QA.
• Familiarity with FDA 21 CFR 820 QSR and ISO 13485 Quality Management Systems.
• Ability to read technical drawings and write reports, with attention to detail.

Responsibilities

• Reads and understands Quality Management System procedures for the position.
• Performs incoming, first piece, in-process and final inspections per specifications and documents results.
• Prepares Nonconforming Material Reports (NCMR) and Customer Deviation Requests (CDR) as needed.
• Maintains accurate records in QA database for inspection results and nonconforming material handling.
• Reviews and approves material and special process certifications.
• Prepares documentation for finished product final release.
• Reviews and releases for distribution, sterile product from Customer Inventory.
• Verifies Device History Records prior to scanning into Document Control System.
• Executes protocols and supports Engineering on Gage R&R and Component Qualification.
• Ensures QA philosophy is disseminated and maintain knowledge of QA standards.

Skills

Micrometers & calipers

Coordinate Measuring Machines

Non-contact instruments

Quality inspection procedures

FDA QSR awareness

Education

High School diploma or equivalent

Job description

Primo Medical Group, Inc. is a leader in medical devices and precision machined components seeking a Quality Inspector for 2nd shift. You will perform incoming, in-process, and final inspections, document results, and prepare NCMR/CDR when discrepancies arise.

You will maintain QA records, verify certifications, and assist with device history records and final release documentation, contributing to compliance with FDA QSR and ISO 13485 standards.