Quality Control Associate

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

Job summary

Traferox Technologies Inc. is seeking a Quality Associate for a 12-month temporary full-time role in Mississauga.

The position supports the Quality and Regulatory department, ensuring inspection records are reviewed, approved and archived, with emphasis on nonconformances and GMP compliance. You will work in a clean manufacturing setting, coordinate with production, review batch records, and prepare release documentation.

Qualifications

• High School diploma is required; post-secondary diploma is an asset.
• 1–2 years in a regulated manufacturing environment preferred.
• Experience in a cleanroom/controlled environment is an asset.
• Experience with computerized document control systems.

Responsibilities

• Coordinate incoming activities with production and review/approve inspection records.
• Inspect, test, and sample materials and products for defects and deviations.
• Reject and quarantine unacceptable parts and initiate non-conformances.
• Follow GMP and quality system controls for records, traceability and nonconforming materials.
• Review and approve batch records and production documentation for accuracy.
• Prepare product release documentation and inventory control.
• Assist in production shipment paperwork and electronic distribution records.
• Raise issues to supervisors regarding abnormalities, low yield, or recurring rejects.
• Assist with cleaning and housekeeping in the manufacturing area.
• Monitor operations to ensure procedures are followed and suggest improvements.
• Communicate product failures and customer complaints to manufacturing.
• Other duties as assigned.

Skills

Attention to detail

Reading engineering drawings

Reading instructions

Excel

SharePoint

Work ethic

Communication

Interpersonal skills

Education

High School diploma

Post-secondary diploma (asset)

Tools

Microsoft Excel

SharePoint

Job 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.

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.

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

Reports to: Quality Control Team Lead

Salary Range: $45,000 - $55,000 annually

Hours: 37.5 Hours Per Week

Shifts: Days, Monday - Friday

Status: Temporary Full-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

• Attention to detail.
• 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.