Senior QMS​/Quality Engineer ( Medical Devices

Position: 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 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)
FDA Quality Management System Regulation (QMSR)
Health Canada Medical Device Regulations
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

Preferred eQMS Experience

Experience with one or more of the following:

Greenlight Guru
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)
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…