Senior Qms / Quality Engineer ( Medical Devices)

Our direct client is looking for a
Senior Quality Engineer / QMS
with strong background in
Medical Devices,
working onsite in Oakville / Mississauga, ON, Canada.
Senior Quality Engineer / QMS - (Medical Device)Onsite role, Monday – Friday
Employment Type: Full-Time
Senior Quality Management System (QMS) Quality Engineer
Position SummaryThe Senior Quality Management System (QMS) Quality Engineer is a technical leader responsible for maintaining, improving, and ensuring the effectiveness of the Company's Quality Management System (QMS) and electronic Quality Management System (eQMS). This individual partners closely with Quality, Regulatory Affairs, R&D, Manufacturing, Operations, Supply Chain, and Program Management to ensure compliance with applicable regulatory requirements and industry standards throughout the product lifecycle.
The Senior QMS Quality Engineer will lead quality system initiatives including CAPA, change control, document control, training, audits, supplier quality, management review, risk management, and continuous improvement activities. This role will serve as a key quality systems resource supporting product development, verification, validation, commercialization, and post-market activities within a regulated medical device environment.
Diagnostics, point-of-care diagnostics, molecular diagnostics, or IVD experience is strongly preferred.
QualificationsEducationBachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Quality, or a related technical discipline.
ExperienceMinimum 7 years of Quality Engineering or Quality Systems experience within a regulated medical device environment.Minimum 5 years supporting and maintaining Quality Management Systems compliant with ISO 13485 and FDA requirements.Demonstrated experience administering and maintaining electronic Quality Management Systems (eQMS).Experience supporting FDA inspections, MDSAP audits, ISO 13485 certification audits, and customer audits.Experience supporting product development, design controls, verification, validation, and commercialization activities.Diagnostics, IVD, point-of-care diagnostics, molecular diagnostics, or laboratory instrumentation experience strongly preferred.
Required Technical ExpertiseQuality Management Systems (QMS)Electronic Quality Management Systems (eQMS)FDA Quality Management System Regulation (QMSR)Health Canada Medical Device RegulationsCAPA, Nonconformance, Deviation, and Change Control SystemsInternal Auditing and Audit ManagementDocument Control and Training SystemsSupplier Quality ManagementDesign Controls and Product Development ProcessesRoot Cause Analysis and Corrective Action MethodologiesData Integrity Principles (ALCOA+)Quality Metrics, Reporting, and Dashboard Development
Preferred eQMS ExperienceExperience with one or more of the following:
Greenlight GuruEquivalent regulated eQMS platforms
Preferred CertificationsASQ Certified Quality Engineer (CQE)ASQ Certified Quality Auditor (CQA)ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)Lean Six Sigma Green Belt or Black BeltRegulatory Affairs Certification (RAC)
Success MeasuresEffective maintenance and continuous improvement of the Quality Management System.Successful completion of external audits, certification audits, and regulatory inspections.Timely and effective closure of CAPAs, nonconformances, and change controls.High levels of document control and training compliance.Effective utilization and continuous improvement of the eQMS platform.Successful support of product development, verification, validation, and commercialization activities.Continuous improvement in quality system effectiveness, compliance, and operational efficiency.Strong cross-functional partnerships supporting organizational quality objective
Key ResponsibilitiesQuality Management System LeadershipMaintain and continuously improve the Quality Management System (QMS) in accordance with applicable regulatory requirements and industry standards.Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, MDSAP, Health Canada Medical Device Regulations, and internal procedures.Support development, implementation, and continuous improvement of quality policies, procedures, and processes.Monitor quality system performance and identify opportunities for improvement.Support organizational readiness for regulatory inspections, certification audits, and commercialization activities.
eQMS Administration & Process OwnershipServe as a primary administrator and business process owner for the electronic Quality Management System (eQMS).Configure and maintain workflows associated with document control, training, CAPA, nonconformance, change control, complaints, supplier quality, and audits.Support eQMS implementations, upgrades, enhancements, validation activities, and data migrations.Develop reports, dashboards, and metrics to monitor quality system effectiveness.Partner with IT and software vendors to maintain compliant and efficient system functionality.Drive user adoption and continuous improvement of eQMS capabilities.
CAPA, Nonconformance & Change ControlLead and facilitate CAPA, nonconformance, deviation, and change control processes.Conduct and support root cause investigations using structured problem-solving methodologies.Ensure corrective and preventive actions are appropriately implemented and verified for effectiveness.Monitor quality system trends and identify systemic improvement opportunities.
Audit & Inspection ReadinessPlan, conduct, and support internal audits.Participate in supplier audits, customer audits, certification audits, and regulatory inspections.Manage audit findings and ensure timely closure of corrective actions.Maintain a state of continuous audit readiness across the organization.
Document Control & TrainingSupport document lifecycle management including creation, review, approval, revision, and archival.Ensure training requirements are established and maintained.Monitor training compliance and effectiveness.Support development and maintenance of quality system documentation and records.Support design control activities throughout product development.Participate in design reviews, verification, validation, and design transfer activities.Support implementation and maintenance of risk management processes in accordance with ISO 14971.Review design and process changes for quality system and regulatory impact.
Supplier Quality SupportSupport supplier qualification, monitoring, and re-evaluation activities.Participate in supplier audits and supplier corrective action activities.Support supplier performance monitoring and quality agreements.Ensure supplier quality processes align with company quality requirements.
Management Review & Quality MetricsSupport Management Review preparation and execution.Develop and maintain quality system performance metrics and dashboards.Analyze trends and recommend quality system improvements.Present quality system performance data to leadership teams as required.Lead and support quality system improvement initiatives.Drive simplification, harmonization, and optimization of quality processes.Apply risk-based decision making to quality system improvements.Promote a culture of quality and continuous improvement across the organization.
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