Quality Engineer – Medical Devices (ISO 13485, FDA)

Colonial Group; Raynham (MA); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Employee referral incentives

Job summary

Colonial Group in Raynham, MA seeks a proactive Quality Engineer to provide quality leadership across operations, ensuring compliance with customer requirements and regulatory standards. You will drive continuous improvement, reduce quality costs, and support audits to maintain robust quality processes.

The role involves partnering with cross-functional teams to enhance systems, investigate issues, and ensure CAL/ISO alignment while mentoring technicians and guiding MRB discussions for

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Experience with medical devices quality systems and regulatory requirements.
• Knowledge of CAPA, audits, calibration, and non-conformance management.
• Familiarity with ISO 13485, FDA 21 CFR Part 820/11, and MDSAP.

Responsibilities

• Lead quality engineering practices and drive continuous improvement.
• Develop QA specifications, test methods, sampling plans, and procedures.
• Support CAPA investigations, root cause analysis, actions, and verification.
• Maintain calibration programs and audit support activities.
• Ensure ISO 13485 and MDSAP alignment for calibration.
• Prepare for internal/external audits and coordinate evidence collection.
• Provide guidance to QC Technicians and lead quality improvements.
• Ensure conformity with quality system procedures across responsibilities.

Skills

Analytical skills

Problem solving

Interpersonal skills

Organizational skills

Excel proficiency

GD&T understanding

Technical communication

Education

Bachelor's in Engineering or Life Sciences

Equivalent education/experience

Tools

Quality databases

Quality systems software

Excel

Job description

Colonial Group in Raynham, MA seeks a proactive Quality Engineer to provide quality leadership across operations, ensuring compliance with customer requirements and regulatory standards. You will drive continuous improvement, reduce quality costs, and support audits to maintain robust quality processes.

The role involves partnering with cross-functional teams to enhance systems, investigate issues, and ensure CAL/ISO alignment while mentoring technicians and guiding MRB discussions for