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 lifecycles.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 regulationsAdminister eQMS workflows, upgrades, validation, reports, and dashboardsLead CAPA, nonconformance, deviation, and change control processesSupport internal audits, inspections, certification audits, and corrective actionsDevelop quality metrics and recommend system improvementsRequirements:
Bachelor's degree in engineering, biomedical engineering, life sciences, quality, or related disciplineSeven years of Quality Engineering or Quality Systems experience in medical devicesFive years maintaining QMS compliant with ISO 13485 and FDA requirementsExperience administering eQMS and supporting audits or inspectionsDiagnostics, IVD, or point-of-care experience strongly preferredBring senior QMS leadership, eQMS administration, audit readiness, and medical device quality expertise to this onsite assignment.
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