At a Glance
- Tasks: Lead quality management systems for medical devices and ensure compliance with regulations.
- Company: Join a leading medical device company in Oakville or Mississauga.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and innovation.
- Why this job: Make a real impact on healthcare by ensuring product quality and safety.
- Qualifications: Bachelor's degree and extensive experience in Quality Engineering for medical devices.
The predicted salary is between 82800 - 101200 $ per year.
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 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.
Senior QMS Quality Engineer Medical Devices in Mississauga employer: Avenue 45
As a Process Excellence Engineer in the vibrant Toronto/Mississauga area, you will join a forward-thinking company that prioritizes continuous improvement and operational excellence. With a strong focus on employee growth, you will have access to training in Lean and Six Sigma methodologies, fostering a culture of innovation and collaboration. The competitive salary range of $135,000 to $170,000 reflects the value placed on your expertise, while the potential for hybrid work arrangements offers flexibility in a dynamic work environment.
