Senior Specialist, Operations Quality
$72,400–$96,600 year
HybridHamilton, Ontario, Canada
Job Summary
Collaborate with Global Logistics & Operations to maintain the quality management system in accordance with ISO standards, GMP, and Canadian regulatory requirements. Act as the key contact for quality activities within Operations, reviewing programs impacting the QMS governing regulated product distribution in Canada. Implement the Validation Program, oversee associated plans and protocols, and manage NCs and CAPAs with strict attention to accuracy and timelines. Facilitate problem-solving techniques and drive quality objectives and KPIs for Operations. Proactively promote a culture of inclusiveness while exemplifying Stryker's values of Integrity, Accountability, People, and Performance.
Required Qualifications
- Working knowledge of ISO 9001 requirements
- Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics
- University degree in Science, Engineering or related field
- Minimum 3+ years' experience in regulatory affairs and/or quality assurance
Desired Qualifications
- Post-graduate diploma in Regulatory Affairs or Quality Assurance
- Medical Device and/or Pharmaceutical experience
- Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire
- High standard of integrity and ability to meet deadlines
- Highly organized and able to prioritize tasks
- Project management and report writing
- Strong oral and written communication skills with both internal and external contacts
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