Senior QMS Quality Engineer Medical Devices

Lead QMS and eQMS effectiveness for medical devices onsite in Oakville or Mississauga, Ontario, Monday through Friday. Apply quality systems expertise across regulated product life cycles.
This Senior Quality Management System Quality Engineer partners with Quality, Regulatory Affairs, R&D, Manufacturing, Operations, Supply Chain, and Program Management. You will support CAPA, audits, change control, document control, training, supplier quality, risk management, and continuous improvement. The work spans product development, verification, validation, commercialization, and post-market activities.

Key Responsibilities:

Maintain QMS compliance with FDA QMSR, ISO 13485, and Health Canada regulations
Administer eQMS workflows, upgrades, validation, reports, and dashboards
Lead CAPA, nonconformance, deviation, and change control processes
Support internal audits, inspections, certification audits, and corrective actions
Develop quality metrics and recommend system improvements
Requirements:
Bachelor's degree in engineering, biomedical engineering, life sciences, quality, or related discipline
Seven years of Quality Engineering or Quality Systems experience in medical devices
Five years maintaining QMS compliant with ISO 13485 and FDA requirements
Experience administering eQMS and supporting audits or inspections
Diagnostics, IVD, or point-of-care experience strongly preferred
Bring senior QMS leadership, eQMS administration, audit readiness, and medical device quality expertise to this onsite assignment.