Company Description

Traferox creates, manufactures, and commercializes products used to transplant solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox currently sells the TorEx Lung Perfusion System and the X°Port Lung Transport Device. Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives.

Traferox Technologies Inc.

Job Description

Department: Quality and Regulatory

Location: 3505 Laird Road, Mississauga, Ontario

Reports to: Vice-President, Quality and Regulatory

Status: Permanent Full-Time

Closing date: November 19, 2025

Duties and Responsibilities:

• Champion a culture of continuous process improvements using methodologies such as Lean, Six Sigma and the latest advances in automation. Spearhead quality improvement initiatives to continuously improve quality system and production processes.
• Develop and implement quality strategies that anticipate the future needs of the business to ensure compliant, sustainable growth.
• Implement and maintain quality system procedures and work instructions to ensure company compliance with global regulations and standards.
• Ensure the routine maintenance of QMS records and metrics analysis for production-related processes (inspection, equipment, facilities and environment, deviations, nonconformances).
• Report to Management on the performance (metrics) of the Quality Management System related to production.
• Manage a team of QA/QC personnel, including assigning tasks and monitoring performance.
• Manage production quality control activities such as incoming inspection, in-process and final device testing, product release, and shipping.
• Ensure devices produced under the quality system and their associated records are compliant with required standards, regulations, and internal specifications prior to product release.
• Initiate, track progress and ensure timely closure of product nonconformance reports and deviations.
• Contribute to root cause analysis of product-related issues such as complaints, CAPAs, deviations, and non-conformances.
• Trend product-related quality events such as complaints, non-conformances and deviations to provide input to product quality improvement initiatives.
• Monitor and maintain procedures related to product design and change control, production processes, and validated processes such as sterilization and sterile barrier manufacturing.
• Participate in supplier qualification activities including on site audits.
• Participate in the internal audit program, external quality audits and site inspections.
• Perform employee training as needed and ensure training records are maintained for company personnel.
• Participate in design and development activities including design transfer to production and process validation. Ensure that Medical Device Files/ Device Master Records are maintained for the company’s products.
• Ensure that software used in production processes is validated.
• Other duties as assigned.

Qualifications

Education:

• Minimum B.SC or B. Eng in engineering or life sciences discipline
• QMS Internal or Lead auditor certification
• Quality (ASQ) or other certifications an asset

Experience:

• 3-5 years of experience in healthcare/medical device production
• Experience working in a cleanroom/controlled environment is an asset.

Skills and Knowledge:

• Knowledge of a quality improvement methodologies equivalent to Lean and Six Sigma
• Knowledge of ISO 13485 and ISO 14971
• Knowledge of FDA and EU regulations
• GMP- Good Manufacturing Practice
• Competent Written and Oral communication
• Proven team player with good problem-solving skills.

Additional Information

We thank all applicants for their interest, however, only those selected for further consideration will be contacted.