Quality Control Associate

University Health Network; Mississauga; Hybrid; CAD 45,000 - 55,000; Full time

Job summary

Traferox Technologies Inc. is seeking a Quality Assurance/Control support role in Mississauga within the Quality and Regulatory department. You will coordinate inspection records, review batch documents and help release finished goods into inventory.

The position is a 12-month temporary full-time contract with 37.5 hours per week, offering CAD 45,000–55,000 annually. Prior experience in a regulated manufacturing environment and proficiency with Excel/SharePoint are preferred.

Qualifications

• Education and experience in a regulated manufacturing environment are preferred.
• Experience reading engineering drawings and applying specifications.
• Familiarity with document control systems is advantageous.

Responsibilities

• Coordinate inspection records with production and issue nonconformances as required.
• Inspect, test, and sample materials and products for defects and deviations.
• Reject and quarantine unacceptable parts and initiate NC reports when needed.
• Maintain documentation controls and traceability per GMP practices.
• Review batch records and production documentation for accuracy.
• Prepare release documentation to release finished goods.
• Assist in production paperwork and electronic distribution records.
• Communicate issues to manufacturing and QA teams for corrective actions.

Skills

Reading drawings

Verbal communication

Written communication

Organization

Interpersonal skills

Strong work ethic

Team mindset

Education

High School diploma

Post-secondary diploma (technical/quality)

Tools

Microsoft Excel

SharePoint

Job description

• Compensation: CAD 45000 - CAD 55000 - yearly

Company Description

Company Profile:

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.

Location:

Work will be performed primarily in the company’s main Traferox facility located at 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5 and 3505 Laird Rd. Unit 16, Mississauga, ON L5L 5Y7, Ontario.

Minimal travel (<10%) is expected.

Job Description

Union:Non-Union
Number of Vacancies:1
New or Replacement Position:Replacement
Site:2400 Skymark Avenue,Mississauga
Department:Quality and Regulatory
Reportsto: Quality Control Team Lead
Salary Range:$45,000 - $55,000 annually
Hours:37.5 Hours Per Week
Shifts:Days,Monday - Friday
Status: TemporaryFull-time (12-month contract)
Closing Date:Open until filled

Duties and Responsibilities:

• Coordinate the incoming activities with production, reviewing, approving and archiving inspection records and issuing nonconformances as required.
• Inspect, test, and sample materials, parts, and products at all stages of manufacturing for defects and any deviations from specifications.
• Reject and quarantine unacceptable or failing parts, initiating non-conformance material reports when required.
• Follow relevant aspects of good manufacturing practices and the company’s quality system with respect to document and record controls, material identification and traceability, control of nonconforming materials, and deviations.
• Review and approve batch records, production documentation, and quality control records to ensure completion, accuracy, and adherence to good documentation practices.
• Prepare product release documentation to release finished goods into inventory.
• Assist in reviewing and approving production shipment paperwork, records and creating distribution records in electronic database.
• Raise issues to manufacturing and QA supervisors about any abnormality in the goods, low yield, or recurring rejects.
• Assist production team with cleaning and housekeeping activities in the manufacturing environment.
• Observe and monitor manufacturing operations to ensure conformance to procedures and to recommend process improvements.
• Awareness of product failure modes and customer complaints. Communication of such issues to manufacturing personnel.
• Other duties as assigned.

Qualifications

Education:

• A High School diploma is required. Post-secondary diploma in a technical or quality-related field would be an asset.

Experience:

• 1-2 years experience in a regulated manufacturing environment (e.g., medical devices, pharmaceutical, food, automotive, etc.)
• Experience working in a cleanroom/controlled environment is an asset.
• Experience working with computerized document control systems.

Skills:

• Ability to read and understand engineering drawings and specifications
• Ability to read and interpret instructions and communicate effectively (verbally and written).
• Hands-on experience with Microsoft Excel and SharePoint
• Strong work ethic and passion to learn and contribute as a member of a high performing team.
• Excellent communication and organization skills
• Strong interpersonal skills

Additional Information

We thank all applicants for their interest in this position with Traferox Technologies Inc. Please note that only candidates selected for an interview will be contacted.

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