Validation Engineering Leader, QA & CQV

STICA STEMCELL Technologies Canada Inc.

Burnaby

On-site

CAD 117,000 - 175,000

Full time

6 days ago
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Job summary

STEMCELL Technologies in Canada seeks a Manager, Validation Engineering to lead a team of quality validation engineers, shape QA validation strategies, and ensure regulatory compliance across our facilities. You will direct CQV, maintain QMS, monitor KPIs, and provide cross‑functional guidance to align validation practices with ISO 13485, ISO 9001 and FDA 21 CFR requirements.

This onsite leadership role offers a competitive salary, comprehensive benefits, and opportunities to advance quality and

Qualifications

  • Bachelor’s degree in Sciences or Engineering (required).
  • 8+ years in quality assurance in regulated environments.
  • ISO 13485, ISO 9001 and FDA 21 CFR knowledge and experience.

Responsibilities

  • Lead, direct, and review the work of validation engineers and set performance standards.
  • Maintain Quality Management Systems (QMS) and CQV controls.
  • Drive continuous improvement in QA processes by monitoring KPIs and trends.
  • Provide technical guidance and allocate resources across multi-disciplinary teams.
  • Collaborate cross-functionally to integrate quality and compliance into operations.

Skills

Leadership
QA Validation
RegulatoryCompliance
Cross-functionalCollaboration
Mentoring

Education

Bachelor's degree in Sciences or Engineering

Job description

STEMCELL Technologies in Canada seeks a Manager, Validation Engineering to lead a team of quality validation engineers, shape QA validation strategies, and ensure regulatory compliance across our facilities. You will direct CQV, maintain QMS, monitor KPIs, and provide cross‑functional guidance to align validation practices with ISO 13485, ISO 9001 and FDA 21 CFR requirements.

This onsite leadership role offers a competitive salary, comprehensive benefits, and opportunities to advance quality and

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