S

STEMCELL Technologies

Manufactures and sells life-science research tools

Manager, Validation Engineering

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBurnaby, BC, CanadaCA$116.7k - CA$175.1k /yrIn-person

About the Job

Requirements

  • A bachelor's degree in Sciences or Engineering and at least 8 years of progressive quality assurance experience in a regulated industry are required.
  • One to three years of direct experience leading, supervising, or mentoring teams is required.
  • Specialized and extensive knowledge of Quality System regulatory requirements, including ISO 13485, ISO 9001, and FDA 21 CFR regulations, is required.
  • Practical experience implementing, managing, and auditing Quality Management Systems is required.
  • The ability to balance regulatory compliance with business and operational requirements is required.

Responsibilities

  • Lead, direct, and review the work of quality validation engineers; establish annual goals and performance standards; identify training needs; and recommend adjustments to training materials.
  • Oversee and maintain Quality Management Systems, operational standards, and procedural controls necessary for Commissioning, Qualification and Validation.
  • Direct continuous improvement in quality assurance processes by monitoring and evaluating metrics and key performance indicators, analyzing effectiveness, recognizing trends, and implementing operational enhancements.
  • Manage technical guidance and resource allocation across project teams engaged in multidisciplinary product development, lifecycle management, and design control.
  • Collaborate cross-functionally to integrate quality knowledge and compliance protocols into business operations and resolve complex quality issues.

Desired Qualifications

  • Experience with Computer System Validation is an asset.

About the Company

STEMCELL Technologies

Manufactures and sells life-science research tools

STEMCELL Technologies makes tools and reagents for life science research, including cell culture media, cell separation reagents, antibodies, cytokines, and robotic instruments. It designs, manufactures, and sells over 2,500 products to labs and biotech companies in more than 70 countries. Its products help scientists grow, maintain, and isolate specific cell types, and the company offers services like contract research and scientific training. Privately owned and reinvesting profits into R&D, it emphasizes long-term quality and a large, globally available catalog to support fields like stem cell biology, immunology, cancer, and regenerative medicine.

Company size
1,001-5,000
Company stage
Grant
Total funding
$99.2M
Headquarters
Vancouver, Canada
Founded
1993

Recently Posted Jobs

Explore more opportunities at STEMCELL Technologies

See more jobs