Senior Quality Engineer, Medical Devices (ISO 13485)

Michael Page; Canton (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Michael Page is seeking a Senior Quality Engineer to support and continuously improve a robust Quality Management System in a medical device manufacturing environment in Canton, MA. You will lead quality initiatives, perform risk management, and drive continuous improvement across cross‑functional teams.

Responsibilities include CAPA, MRB, FMEA, MSA, Gage R&R, supplier quality, audits, and verification activities. A strong background in ISO 13485 and data‑driven decision making is required.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline.
• 5-10 years of quality engineering experience in medical device or regulated manufacturing.
• Strong understanding of ISO 13485 QMS and regulatory compliance.
• Experience with CAPA, nonconforming materials, calibration systems, and root cause analysis methodologies.

Responsibilities

• Support the effectiveness, maintenance, and continuous improvement of the Quality Management System (QMS).
• Partner with leadership and cross-functional teams to ensure ISO 13485 compliance.
• Mentor and train Quality Engineers and support onboarding and development.
• Provide shop floor quality support, troubleshoot manufacturing issues, and lead root cause investigations.
• Own Risk Management activities, including FMEA and risk mitigation.

Skills

Quality engineering

ISO 13485

CAPA

Root cause analysis

Minitab

Data analysis

GD&T

MSA

Metrology

RCA

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Tools

Minitab

ERP systems

Microsoft Office

Job description

Michael Page is seeking a Senior Quality Engineer to support and continuously improve a robust Quality Management System in a medical device manufacturing environment in Canton, MA. You will lead quality initiatives, perform risk management, and drive continuous improvement across cross‑functional teams.

Responsibilities include CAPA, MRB, FMEA, MSA, Gage R&R, supplier quality, audits, and verification activities. A strong background in ISO 13485 and data‑driven decision making is required.