Validation Engineering Lead - QA & Compliance

STEMCELL Technologies Inc; Burnaby; On-site; CAD 117,000 - 175,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Career development opportunities

Job summary

STEMCELL Technologies Inc. in Canada seeks a Manager, Validation Engineering to lead a team responsible for quality assurance validation strategies and regulatory compliance across CQV activities.

You will shape validation frameworks and mentor engineers in a fast-paced, science-driven environment. You will collaborate cross-functionally to align QA practices with ISO and FDA standards, drive continuous improvement, and ensure safety and quality across facilities while delivering strategic

Qualifications

• Bachelor’s degree in Sciences or Engineering with a minimum of 8 years of progressive experience in quality assurance in a regulated industry
• 1 to 3 years of direct experience leading, supervising, or mentoring teams
• Specialized and extensive knowledge of Quality System regulatory requirements (ISO 13485, ISO 9001, and FDA 21 CFR regulations)
• Demonstrated practical experience implementing, managing, and auditing QMS, with experience in Computer System Validation is an asset
• Proven ability to balance regulatory compliance with business and operational requirements

Responsibilities

• Leads, directs and reviews the work of quality validation engineers, establishes annual goals and performance standards, identifies training needs, and recommends adjustments to training materials
• Oversees and maintains Quality Management Systems (QMS), operational standards, and procedural controls necessary for the Commissioning, Qualification and Validation (CQV)
• Directs continuous improvement within quality assurance (QA) processes by monitoring and evaluating metrics and key performance indicators (KPIs) to analyze effectiveness, recognize trends, and implement operational enhancements
• Manages technical guidance and resource allocation across project teams engaged in multidisciplinary product development, lifecycle management, and design control
• Collaborates cross‑functionally to integrate quality knowledge and compliance protocols into business operations and effectively resolves complex quality issues

Skills

Quality Assurance Leadership

Regulatory Compliance

Cross-functional Collaboration

Quality Management Systems

Education

Bachelor’s degree in Sciences or Engineering

Job description

STEMCELL Technologies Inc. in Canada seeks a Manager, Validation Engineering to lead a team responsible for quality assurance validation strategies and regulatory compliance across CQV activities.

You will shape validation frameworks and mentor engineers in a fast-paced, science-driven environment. You will collaborate cross-functionally to align QA practices with ISO and FDA standards, drive continuous improvement, and ensure safety and quality across facilities while delivering strategic