Lead Medical Device Quality & Process Engineer

Vital Bio; Oakville; On-site; CAD 130,000 - 150,000; Full time

Job summary

Vital Biosciences Inc. in Oakville, Ontario, seeks a Senior Manufacturing Quality Engineer to lead manufacturing quality activities across development to sustained production of medical devices.

You will collaborate with Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain and Regulatory Affairs to ensure processes deliver safe, effective products. The role emphasizes process characterization, statistical engineering, validation, and continuous improvement within a

Qualifications

• Bachelor's degree in Mechanical Engineering or related engineering field.
• Strong knowledge of quality systems in medical devices.
• Experience with statistical analysis and design of experiments.

Responsibilities

• Lead manufacturing quality activities supporting NPI, commercialization, and sustaining manufacturing.
• Partner with Manufacturing Engineering during equipment design, process development, and design transfer.
• Develop and execute quality strategies to ensure robust, compliant processes.
• Ensure compliance with ISO 13485, FDA QMSR, ISO 14971 and internal QMS requirements.

Skills

Leadership

Problem-solving

Cross-functional collaboration

Statistical analysis

Education

Bachelor's degree in Mechanical Engineering or related engineering

Tools

Minitab

JMP

Job description

Vital Biosciences Inc. in Oakville, Ontario, seeks a Senior Manufacturing Quality Engineer to lead manufacturing quality activities across development to sustained production of medical devices.

You will collaborate with Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain and Regulatory Affairs to ensure processes deliver safe, effective products. The role emphasizes process characterization, statistical engineering, validation, and continuous improvement within a