Quality Inspector - Raynham

Colonial Group; Raynham (MA); On-site; USD 32,000 - 37,000; Full time

Benefits offered by this job

Employee referral program

Job summary

Colonial Group is seeking a Quality Inspector in Raynham, MA, onsite to ensure incoming materials, in-process components, and finished products meet strict quality and regulatory standards.

You will collaborate with Quality, Manufacturing, and Engineering teams to uphold ISO 13485, FDA QSR, and GMP procedures while maintaining thorough inspection records and calibration documents.

Qualifications

• High school diploma or equivalent.

Responsibilities

• Perform incoming, in-process, and final inspections of materials and products.
• Review manufacturing docs, engineering drawings, specs, and acceptance criteria.
• Complete inspection documentation including DHRs, inspection records, and NCMRs.
• Conduct or support First Article Inspections (FAI).
• Document inspection findings and maintain quality records per procedures.
• Escalate non-conforming materials, products, or processes.
• Support ISO 13485, FDA QSR, and internal procedures compliance.
• Assist with calibration records, CAPAs, NCMRs, and other quality documents.
• Conduct periodic inventory cycle counts in the Quality Inspection area.
• Perform spot checks and audits of quality records.
• Support special inspection requests, investigations, and rework.
• Adhere to QMS and GMP standards.

Skills

Reading drawings & specs

Attention to detail

Documentation skills

Communication skills

Regulated manufacturing experience

Education

High school diploma or equivalent

Technical qualification or degree in Engineering/Manufacturing/Quality

Tools

Calipers

Micrometers

Height gauges

Measurement tools

Job description

Quality Inspector

Location: Raynham MA
Employment Type: Full-time - onsite

Join Our Team

We are seeking a detail-oriented and quality-focused Quality Inspector to play a critical role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance. This role is responsible for inspecting incoming materials, in-process components, and finished products, while supporting our Quality Management System and regulatory requirements.

If you have experience in manufacturing quality inspection, enjoy working with precision measurement equipment, and take pride in delivering excellence, we would love to hear from you.

The Role

As a Quality Inspector, you will be responsible for ensuring that all products received from suppliers and released from manufacturing comply with specifications, company standards, and applicable regulatory requirements.

You will work closely with Quality, Manufacturing, Supply Chain, and Engineering teams to identify and address quality concerns, support inspection activities, and maintain accurate quality documentation.

What you’ll do

• Perform incoming, in-process, and final inspections of materials and products.
• Review manufacturing documentation, engineering drawings, specifications, and acceptance criteria.
• Complete and maintain inspection documentation, including:
  • Device History Records (DHRs)
  • Inspection records
  • Non-Conforming Material Reports (NCMRs)
• Conduct or support First Article Inspections (FAI) for new products and supplier changes.
• Utilize inspection and measurement equipment, including calipers, micrometers, height gauges, and other testing tools.
• Accurately document inspection findings and maintain quality records in accordance with company procedures.
• Identify, document, and escalation 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 Quality Management System (QMS) requirements in line with ISO 13485 and Good Manufacturing Practice (GMP) standards.

About You

To be successful in this role, you will be highly organised, methodical, and committed to maintaining high quality standards. You will have excellent attention to detail and be comfortable working within a regulated manufacturing environment.

Essential 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 of 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.

Preferred

• 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.

Why Join Us?

• The base pay range for this position is $22.60- $27.40 per hour. The specific pay offered may be influenced by a variety of factors, including the candidate’s experience, education, and skill set."

• Employee referral program where you can earn incentives for each successful hire you recommend