Sr QA Specialist
On-site · Kanata, Ontario, Canada
Job Summary
Senior QA Specialist responsible for developing, maintaining, and evolving Quality Assurance Systems to ensure compliance with FDA, Health Canada, ISO 9001, ISO 13485, and CE Mark requirements for drugs and medical devices. Leads quality planning and continuous improvement, conducts internal and supplier audits, guides development teams on regulatory QA requirements, establishes CAPA and corrective actions for non-conformances, and provides QA training across production, QC, R&D, and other groups. Supports customer and regulatory audits, maintains quality data analysis, and may participate in drug/device release activities. Requires an undergraduate degree in Life Sciences or Engineering (or related college diploma with substantial QA/QC experience), ASQ asset, and 3-5 years in a pharmaceutical or medical device environment; based in Kanata, Ontario with on-site responsibilities and hybrid work options.
Required Qualifications
- Undergraduate degree in Life Sciences or Engineering or College diploma with significant industry experience (3-5+ years) in QA/QC in pharmaceutical/medical device environment
- ASQ certification asset
- Up-to-date knowledge of FDA, Health Canada, and European regulations; GMP experience
- Experience with quality systems, audits (internal, supplier, customer, regulatory)
- Ability to lead CAPA, root cause analysis, and continuous improvement
- Strong collaboration across cross-functional teams (Engineering, R&D, Production, QC, IT, HR)
- Knowledge of cGMP, ISO quality standards, and regulatory requirements for drugs/devices
- Ability to train staff on QA procedures and GMP/Quality System topics
- May perform drug or device product release activities
- Strong problem-solving, analytical skills, and organizational abilities
- Willingness to work on-site in Kanata, Ontario
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