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 searching for a Quality Inspector to join our team! We are a leader in the development of medical devices and precision machined components. There are currently three locations with a fourth nearing completion. Primo is a dynamic, innovative company offering competitive salary, excellent benefits and has a strong focus on the training and professional advancement of its employees.

Quality Inspector 2nd Shift

Summary: Perform all aspects of Incoming, In-process and Final Inspection of materials, components and finished medical products. The QC Inspector performs the following duties:

Essential Duties and Responsibilities:

• Reads and understands all Quality Management System procedures related to the position / function within the organization.
• Performs incoming, First Piece, in-process and final inspection per relevant specifications. Documents the results of these inspections on the appropriate Quality Plans.
• Prepares Nonconforming Material Reports (NCMR) and Customer Deviation Requests (CDR) as applicable for discrepant materials and components.
• Maintain accurate records within the Quality Assurance Database for inspection results and nonconforming material handling.
• Review and approve material and special process certifications.
• Prepares required documentation for finished product final release.
• Reviews and releases for distribution, sterile product from Customer Inventory.
• Review and verify Device History Records to ensure that all required documents are present, complete and accurate prior to scanning them into the Document Control System.
• Execute protocols and support Engineering on special projects such as Gage R&R and Component Qualification.
• Ensure that the Quality Assurance philosophy is disseminated to personnel in organization.
• Maintain a working knowledge of industry Quality Assurance standards

Supervisory Responsibilities

This position has no direct supervisory responsibilities

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

High School diploma or equivalent and three to five years’ experience in a Manufacturing or Quality Assurance environment or equivalent combination of education and experience. Working knowledge of FDA 21CFR820 Quality System Regulations (QSR) and ISO 13485 Quality Management Systems.

Technical Skills

• Micrometers, calipers, thread gages and similar manual instruments,
• Surface-plate set-ups, Micro-Hites, drop indicators
• Coordinate Measuring Machines
• Non-contact instruments such as comparators and vision systems.

Language Skills

• Ability to read and interpret technical drawings and specifications.
• Ability to write reports and business correspondence.
• Ability to effectively present information and respond to questions from managers, employees and suppliers.

Mathematical Skills

Ability to work with basic mathematical concepts

Reasoning Ability

• Ability to solve practical problems using a common sense approach.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Attention to detail.

Physical Ability

20/20 corrected vision and / or ability to distinguish colors, see fine imperfection and flawsComputer Skills
Individual should have a good working knowledge of the elements within Microsoft Office and Adobe Acrobat.