Senior QMS Quality Engineer - Medical Devices (Onsite)

Avenue 45; Mississauga; On-site; CAD 90,000 - 130,000; Full time

Job summary

Avenue 45 in Ontario is seeking a Senior Quality Management System (QMS) Quality Engineer to lead and maintain our QMS/eQMS in a regulated medical device environment. You will partner with Quality, Regulatory Affairs, R&D, Manufacturing, and Operations to ensure regulatory compliance throughout the product lifecycle.

The role focuses on CAPA, change control, document control, audits, supplier quality, and continuous improvement, supporting development, verification, validation, and

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 7+ years in quality engineering or quality systems in regulated medical devices.
• Experience with ISO 13485, FDA requirements, and eQMS administration.
• Experience with FDA inspections, MDSAP audits, and regulatory certifications.
• Strong problem-solving, documentation, and cross-functional collaboration.

Responsibilities

• Maintain and improve QMS/eQMS across the product lifecycle.
• Lead CAPA, change control, document control, and training.
• Support internal and external audits, inspections, and certifications.
• Collaborate with QA, Regulatory, R&D, Manufacturing, and Supply Chain.
• Drive continuous improvement and data-driven quality metrics.

Skills

QMS

eQMS

CAPA

Audit management

Documentation

Supplier quality

Risk management

Design controls

Root cause analysis

Data integrity

Quality metrics

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Greenlight Guru

Job description

Avenue 45 in Ontario is seeking a Senior Quality Management System (QMS) Quality Engineer to lead and maintain our QMS/eQMS in a regulated medical device environment. You will partner with Quality, Regulatory Affairs, R&D, Manufacturing, and Operations to ensure regulatory compliance throughout the product lifecycle.

The role focuses on CAPA, change control, document control, audits, supplier quality, and continuous improvement, supporting development, verification, validation, and