Senior Specialist, Operations Quality
Core
Ensures quality management system compliance with ISO standards, GMP, and Canadian regulations for regulated product distribution.
Role type
Senior Specialist, Operations Quality
Builds
Quality Management System (QMS) for regulated product distribution in Canada
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001 knowledge, Canadian regulatory knowledge (medical devices, CTO, drugs, natural health products, cosmetics), problem-solving techniques (5 Why's, fishbone, 4D's, process mapping), validation program management, NC/CAPA review, quality record maintenance, KPI development
Preferred skills
Trackwise, ComplianceWire, Project management, Report writing, Medical Device/Pharmaceutical experience
Technologies
Excel, Word, PowerPoint, SharePoint, Trackwise, ComplianceWire
Responsibilities
Act as key contact for Quality activities within Operations for Stryker Canada; Review programs and processes impacting the Quality Management System; Implement and maintain the Validation Program; Support and review NCs and CAPAs for Operations; Facilitate Operations teams in applying problem-solving techniques; Support creation of quality objectives/KPIs for Operations; Drive Good Manufacturing Practices and Good Documentation Practices
Seniority
Senior, hands-on IC