Senior Operations Manager

Company Description

Traferox creates, manufactures and commercializes products used to transplant solid organs, employing technologies invented by the surgeon team of the University Health Network (UHN), with the goal to increase availability of donor organs, improve surgical outcomes and save patients’ lives.

Job Description

Union:  Non-Union
Number of vacancies: 1
Site: 26-3505 Laird Road in Mississauga 
Department: Engineering 
Reports to: VP Manufacturing and Service Operations
Salary Range: $100,000 - $140,000 annually
Status: Permanent Full-Time
Closing Date: July 11, 2025

Position Summary:
The Operations Manager is a hands-on leader responsible for the day-to-day execution of manufacturing and supply chain activities at Traferox Technologies. This role plays a critical part in ensuring safe, efficient, and compliant operations in a regulated medical device environment. The ideal candidate has strong experience in production planning, team supervision, MRB processes, and logistics—including cross-border shipping of regulated products. The Operations Manager will also support the company-wide transition to a new facility, including equipment setup, production line validation, and operational startup.

Duties:

Manufacturing & Daily Operations:

• Closely work with the Production Supervisor to manage daily manufacturing floor activities to ultimately ensuring quality, accuracy and efficient production of product lines.
• Troubleshoot operational issues and coordinate immediate corrective actions with production, quality, and engineering teams.
• Execute daily and weekly production plans; adjust schedules and resources to respond to changes in demand or supply.
• Ensure proper documentation and traceability are maintained (DHRs, travelers, batch records).
• Conduct assessment of plant operations, people, equipment, processes and systems and recommend improvements to be implemented.
• Coach and mentor the manufacturing team to become a more efficient producer, encourage continuous improvement and serve as a business partner across the organization.
• Manage the inventory of materials and finished goods to ensure the highest possible service levels with controlled operating costs and delivery performance.
• Develop innovative, cost-effective systems and processes that enable growth and efficiency while measuring results.

Production Planning & Execution:

• Prepare and manage detailed production schedules in coordination with planning and procurement teams.
• Monitor material availability, equipment readiness, and labor allocation to meet planned production targets.
• Communicate priorities and output targets clearly to line staff and supervisors.
   

Facility Setup & Validation Support:

• Support the setting up of new manufacturing lines, equipment relocation, and process readiness as part of the new facility project.
• Assist with execution of IQ/OQ/PQ validation protocols and documentation under guidance of validation and quality teams.
• Coordinate with contractors, suppliers, and internal stakeholders to meet startup milestones.

Supply Chain & Logistics Execution:

• Review supply contracts, relationships, negotiate price and supply terms.
• Oversee day-to-day logistics, inventory movements, and incoming/outgoing shipments.
• Ensure compliance with customs, HTS codes, and documentation for cross-border shipments of medical devices.
• Maintain accurate inventory records and support physical inventory counts or cycle counts.

MRB & Non-Conformance Handling:

• Lead the MRB (Material Review Board) process to evaluate, document, and resolve non-conforming materials or components.
• Initiate root cause investigations and collaborate with QA and engineering on corrective actions.

Team Supervision:

• Direct and support production technicians, warehouse personnel, and material handlers.
• Monitor team performance, provide coaching, and promote a culture of accountability, safety, and continuous improvement.
• Enforce standard operating procedures (SOPs) and good manufacturing practices (GMP).

Qualifications

• Bachelor’s degree or college diploma in Engineering, Operations, Supply Chain, or a related technical field.
• 5–8 years of experience in regulated manufacturing operations (preferably medical devices or pharmaceuticals).
• Hands-on experience with production planning, inventory management, and ERP/MRP systems.
• Familiarity with FDA QSR, ISO 13485, and Health Canada medical device requirements.
• Experience with MRB processes and disposition of non-conforming materials.
• Strong organizational, communication, and problem-solving skills.
• Ability to work effectively on the production floor and collaborate cross-functionally.

Preferred Experience:

• Experience in setting up new production areas or facility transitions.
• Exposure to cleanroom or aseptic operations.
• Knowledge of international shipping regulations and customs documentation for medical devices.