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Quality Control/ Quality Assurance Associate

4 months ago

North York, Canada Thornhill Medical Full time

ABOUT THORNHILL MEDICAL:


Thornhill Medical’s ground-breaking products are designed to be used globally by emergency health care providers, humanitarian, and military medical teams. Thornhill’s oxygen-focused research and applications are transforming patient care in extreme circumstances, while inspiring and enabling other new technologies to unlock vital life-saving solutions. Thornhill Medical’s innovations are in 19+ countries including Ukraine. With a team committed to courage, collaboration and saving lives, Thornhill Medical leads the way in the nimble and precision-focused field of medical technologies.


POSITION SUMMARY:

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


DUTIES & RESPONSIBILITIES:

  • Assists in managing and maintaining the Quality Management System in compliance with ISO 13485 + MDSAP, CMDR, European MDD/MDR, US FDA QSR country specific requirements.
  • Leads control of documents and Standard Operating Procedures (SOPs) within the Quality Management System.
  • Leads/supports the review, control, and release of documents and keeps records in support of the quality management system including maintaining the design history file, device history records, and device master records.
  • Controls testing equipment process.
  • Coordinates quality training process with other departments in the organization and ensures training records are compliant.
  • Assists with releasing products by reviewing/inspecting quality records and products.
  • Assists in the development of technical documents, including incoming inspections.
  • Provides multi-departmental support related to audits and inspections from regulatory agencies (e.g., Health Canada, FDA, European).
  • Considers quality in all aspects of the job and respects procedures and norms.
  • Other duties as assigned.


EDUCATION & EXPERIENCE: 

  • Bachelor’s degree or diploma in electrical or mechanical engineering or related field.
  • Quality Assurance Manufacturing & Management Certificate would be 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.
  • Experience using quality systems.


SKILLS & KNOWLEDGE:

  • Knowledge of ISO 13485 + MDSAP, European MDD/MDR, US FDA QSR requirements.
  • Strong organizational skills with meticulous attention to detail.
  • Strong analytical skills with experience interpreting quality data and presenting to management.
  • Excellent problem solving and troubleshooting skills.
  • Strong time management skills.
  • Self-starter that is highly motivated, creative, and able to work both independently and within a team environment.
  • Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives.
  • Excellent interpersonal and communication skills (verbal and written).
  • Drive to consistently achieve results, even under tough circumstances.
  • Holds self and others accountable to meet commitments.
  • Strong computer skills and proficiency with Microsoft Office suite products (Word, Excel, PowerPoint).


OTHER REQUIREMENTS:

  • Primarily office environment with exposure to production work rooms when required. 
  • Light lifting and bending. 
  • Some travel required.

Thornhill Medical welcomes and encourages applications from all qualified people, including those with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.


We thank all applicants for their interest, however, only those selected will be invited for an interview.