Quality Assurance Specialist

1 week ago

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

Thornhill Medical is a leading manufacturer of innovative medical devices that are transforming patient care in extreme circumstances. Our team is committed to courage, collaboration, and saving lives.

Job Summary

The Quality Control/Quality Assurance Associate is responsible for assisting in the daily operational management of Thornhill Medical's Quality System and ensuring compliance with all quality and regulatory requirements.

Key Responsibilities
  • Quality Management System: Assist in managing and maintaining the Quality Management System in compliance with ISO MDSAP, CMDR, European MDD/MDR, and US FDA QSR country-specific requirements.
  • Document Control: Lead control of documents and Standard Operating Procedures (SOPs) within the Quality Management System.
  • Document Review and Release: Lead/support the review, control, and release of documents and keep records in support of the quality management system, including maintaining the design history file, device history records, and device master records.
  • Testing Equipment Process: Control testing equipment process.
  • Quality Training: Coordinate quality training process with other departments in the organization and ensure training records are compliant.
  • Product Release: Assist with releasing products by reviewing/inspecting quality records and products.
  • Technical Document Development: Assist in the development of technical documents, including incoming inspections.
  • Audit and Inspection Support: Provide multi-departmental support related to audits and inspections from regulatory agencies (e.g., Health Canada, FDA, European).
  • Quality Considerations: Consider quality in all aspects of the job and respect procedures and norms.
Requirements
  • Education: Bachelor's degree or diploma in electrical or mechanical engineering or related field.
  • Experience: 2-3 years of related experience in Mechanical or Electrical Engineering or in a manufacturing/production environment.
  • Quality Management Compliance: Experience in quality management compliance at a medical device company with Class II and III devices is an asset.
  • Quality Systems: Experience using quality systems.
Skills and Knowledge
  • Regulatory Requirements: Knowledge of ISO MDSAP, European MDD/MDR, US FDA QSR requirements.
  • Organizational Skills: Strong organizational skills with meticulous attention to detail.
  • Analytical Skills: Strong analytical skills with experience interpreting quality data and presenting to management.
  • Problem-Solving Skills: Excellent problem-solving and troubleshooting skills.
  • Time Management: Strong time management skills.
  • Collaboration: Self-starter that is highly motivated, creative, and able to work both independently and within a team environment.
  • Communication Skills: Excellent interpersonal and communication skills (verbal and written).
  • Results-Oriented: Drive to consistently achieve results, even under tough circumstances.
  • Accountability: Holds self and others accountable to meet commitments.
  • Computer Skills: Strong computer skills and proficiency with Microsoft Office suite products (Word, Excel, PowerPoint).

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