Quality Specialist

Company Description

About Traferox:
Traferox is a medical technology company transforming the field of organ transplantation. Our mission is to improve transplant outcomes and access through innovative preservation and perfusion technologies grounded in rigorous science. We are the creators of the FDA-cleared X°Port Lung Preservation System and pioneers in next generation lung perfusion systems, setting new standards in donor organ care. 

Job Description

Union:  Non-Union
Number of vacancies: 1
Site: 3505 Laird Road, Unit #16, Mississauga, ON
Department: Quality and Regulatory
Reports to: Quality Manager
Status: Permanent Full-Time

Position Summary:

The position of Quality Specialist will be an integral member of the Quality and Regulatory department. The Quality Specialist will contribute to the development and maintenance of manufacturing and quality system procedures and work instructions to ensure compliance with global regulations and standards in a regulated medical device environment. The ideal candidate has at least 3 years of experience working in an Active Medical Device environment adhering to GMP with a good working knowledge of ISO 13485 and ISO 14971, FDA, EU and HC regulations. The Quality Specialist will be part of the team supporting the company-wide transition to a new facility.

Primary responsibilities include:

• Contribute to the development and maintenance of manufacturing and 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 of production suppliers, processes, equipment and environment.
• Initiate, track progress and contribute to resolution of complaints, CAPAs, deviations, non-conformances, and supplier corrective actions.
• Review and approve product specification sheets and incoming inspection records.
• Participate in internal and external quality system audits.
• Review and complete Device History Record (DHR) for product release approval.
• Report to Management on the performance (metrics) of the production Quality Management System.
• Train and maintain training records for company personnel.
• Contribute to developing training programs for company personnel.
• Manage production equipment maintenance and calibration schedules, addition of new equipment, and investigation of equipment failures.
• Maintain supplier records and perform supplier qualification and evaluation activities including on site audits.
• Assist with the routine production inspection and end-of-line testing.
• Review and approve test records.
• Provide oversight of facility environmental monitoring
• Assist engineering team with production issues debugging and root cause analysis.
• Spearhead quality improvements initiatives to improve production yield.
• Other duties as assigned.

Qualifications

• Excellent organizational and time management skills
• Strong communication skills and technical writing skills
• Ability to work effectively in a team environment
• Ability to exercise initiative and good judgement with ability to multitask
• Ability to function independently with a high level of attention to detail
• Ability to prioritize multiple projects simultaneously
• Excellent interpersonal and communication skills
• Good working knowledge of ISO 13485 and ISO 14971
• Good working knowledge of FDA and EU regulations
• Experience working in GMP- Good Manufacturing Practice environments

Education:

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

Experience:

• Three (3) or more years of experience working in a healthcare/medical device production environment
• Experience working in a cleanroom/controlled environment is an asset