Quality Assurance Associate

21 hours ago

Richmond Hill, Ontario, Canada Thornhill Medical Full time
About Thornhill Medical

Thornhill Medical is a leading manufacturer of medical devices that are transforming patient care in extreme circumstances. Our innovative products are used globally by emergency healthcare providers, humanitarian, and military medical teams.

Job Summary

The Quality Control/Quality Assurance Associate is responsible for ensuring compliance with all quality and regulatory requirements. This role involves managing and maintaining the Quality Management System, leading control of documents and Standard Operating Procedures, and coordinating quality training.

Key Responsibilities
  • Manage and maintain the Quality Management System in compliance with ISO MDSAP, CMDR, European MDD/MDR, and US FDA QSR requirements.
  • Lead control of documents and Standard Operating Procedures within the Quality Management System.
  • Review, control, and release documents, and maintain records in support of the quality management system.
  • Coordinate quality training with other departments and ensure training records are compliant.
  • Assist with releasing products by reviewing quality records and products.
  • Develop technical documents, including incoming inspections.
  • Provide support for audits and inspections from regulatory agencies.
Requirements
  • Bachelor's degree or diploma in electrical or mechanical engineering or a related field.
  • Quality Assurance Manufacturing & Management Certificate is an asset.
  • 2-3 years of related experience in Mechanical or Electrical Engineering or in a manufacturing/production environment.
  • Experience in quality management compliance at a medical device company with Class II and III devices is an asset.
Skills and Knowledge
  • Knowledge of ISO MDSAP, European MDD/MDR, and US FDA QSR requirements.
  • Strong organizational skills with attention to detail.
  • Strong analytical skills with experience interpreting quality data.
  • Excellent problem-solving and troubleshooting skills.
Work Environment

This role is primarily office-based with occasional exposure to production work rooms.

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