Quality Inspector - Raynham

Corin•Raynham, MA

23d•Onsite

About The Position

The Quality Inspector ensures that incoming materials, in-process components, and finished products meet specifications, company standards, and applicable regulatory requirements. The role supports the Quality Management System and works with Quality, Manufacturing, Supply Chain, and Engineering teams to identify and address quality concerns, carry out inspection activities, and maintain accurate quality documentation. The position is full-time and onsite in Raynham, Massachusetts.

Requirements

High school diploma or equivalent.
Experience in a manufacturing quality inspection role, ideally within a regulated industry.
Ability to read and interpret engineering drawings and technical specifications.
Knowledge of inspection methods, measurement techniques, and quality standards.
Experience using inspection equipment such as calipers, micrometers, and gauges.
Strong documentation and record-keeping skills.
Good computer skills and experience using electronic quality systems.
Excellent attention to detail and problem-solving skills.
Strong verbal and written communication skills.

Nice To Haves

Technical qualification or degree in Engineering, Manufacturing, Quality, or a related discipline.
Experience working within medical device, pharmaceutical, aerospace, or other highly regulated industries.
Knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, CAPA, and non-conformance processes.

Responsibilities

Perform incoming, in-process, and final inspections of materials and products.
Review manufacturing documentation, engineering drawings, specifications, and acceptance criteria.
Complete and maintain Device History Records (DHRs), inspection records, and Non-Conforming Material Reports (NCMRs).
Conduct or support First Article Inspections (FAI) for new products and supplier changes.
Use inspection and measurement equipment, including calipers, micrometers, height gauges, and other testing tools.
Document inspection findings and maintain quality records in accordance with company procedures.
Identify, document, and escalate non-conforming materials, products, or processes.
Support compliance with quality system requirements, including ISO 13485, FDA Quality System Regulations, and internal procedures.
Assist with document control activities related to calibration records, CAPAs, NCMRs, and other quality documentation.
Conduct periodic inventory cycle counts within the Quality Inspection area.
Perform spot checks and audits of quality records to ensure accuracy and integrity.
Support special inspection requests, investigations, and rework projects as required.
Adhere to QMS requirements in line with ISO 13485 and Good Manufacturing Practice (GMP) standards.