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)
Location: Oakville / Mississauga, ON (Onsite 5 Days/Week)
Onsite role, Monday – Friday
Employment Type: Full-Time
Senior Quality Management System (QMS) Quality Engineer
Position Summary
The 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.
Qualifications
Education
· Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Quality, or a related technical discipline.
Experience
· Minimum 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 Expertise
· Quality Management Systems (QMS)
· Electronic Quality Management Systems (eQMS)
· ISO 13485
· FDA Quality Management System Regulation (QMSR)
· MDSAP
· Health Canada Medical Device Regulations
· ISO 14971 Risk Management
· CAPA, Nonconformance, Deviation, and Change Control Systems
· Internal Auditing and Audit Management
· Document Control and Training Systems
· Supplier Quality Management
· Design Controls and Product Development Processes
· Root Cause Analysis and Corrective Action Methodologies
· Data Integrity Principles (ALCOA+)
· Quality Metrics, Reporting, and Dashboard Development
· Computer System Validation (CSV)
Preferred eQMS Experience
Experience with one or more of the following:
· MasterControl
· Greenlight Guru
· Veeva
· ETQ Reliance
· TrackWise
· Arena QMS
· Equivalent regulated eQMS platforms
Preferred Certifications
· ASQ Certified Quality Engineer (CQE)
· ASQ Certified Quality Auditor (CQA)
· ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
· ISO 13485 Lead Auditor
· Lean Six Sigma Green Belt or Black Belt
· Regulatory Affairs Certification (RAC)
Success Measures
· Effective 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 Responsibilities
Quality Management System Leadership
· Maintain 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 Ownership
· Serve 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 Control
· Lead 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 Readiness
· Plan, 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 & Training
· Support 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.
Product Development & Risk Management Support
· 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 Support
· Support 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 Metrics
· Support 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.
Continuous Improvement
· 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.
If you are interested, please send me your updated Word Resume, along with your direct phone number and email.
Location: Oakville / Mississauga, Ontario (Onsite 5 Days per Week)
