Senior Quality Engineer, Validation — CQV Lead

STEMCELL Technologies Inc; Burnaby; On-site; CAD 95,000 - 142,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Career development opportunities

Job summary

STEMCELL Technologies Inc is seeking a Senior Quality Engineer, Validation to lead CQV strategies for equipment, facilities and processes. You will ensure regulatory alignment and drive audit-ready documentation while supporting ongoing manufacturing operations and new product launches.

The role involves risk assessments, FMEA, validation testing for software and equipment, and process improvements to strengthen quality systems.

Qualifications

• Bachelor’s degree in Engineering with 6–10 years of relevant experience; Master’s degree with 4+ years is acceptable.
• Knowledge of mechanical, chemical, electrical and software engineering disciplines and applying them to manufacturing and product development.
• Experience with ERP and QMS in ISO 13485 or GMP environments; exposure to sterile/high-volume manufacturing is a plus.
• Familiarity with regulatory standards including ISO 13485, FDA 21 CFR Part 820, and ISPE; ability to develop risk documentation and apply risk-based validation.
• Strong organizational, prioritization, and project management skills; able to support products per specifications.

Responsibilities

• Develop comprehensive validation strategies for processes, systems and equipment in line with regulatory requirements and best practices.
• Perform risk assessments and determine critical validation requirements and documentation.
• Conduct FMEA and other risk management activities to identify and mitigate validation risks.
• Lead complex validation testing for equipment, utilities, software and processes; ensure performance within defined parameters.
• Identify opportunities to improve validation processes through data analysis and non-conformance review.

Skills

Certified Quality Engineer

Quality Systems

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Software, or Biomedical)

Master’s degree in Engineering

P.Eng. designation (asset)

Tools

ERP systems

Quality Management Systems (QMS)

Job description

STEMCELL Technologies Inc is seeking a Senior Quality Engineer, Validation to lead CQV strategies for equipment, facilities and processes. You will ensure regulatory alignment and drive audit-ready documentation while supporting ongoing manufacturing operations and new product launches.

The role involves risk assessments, FMEA, validation testing for software and equipment, and process improvements to strengthen quality systems.