Quality Assurance Specialist

DSVMilton, YT
Hybrid

About The Position

The Quality Assurance Specialist supports the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) across site operations. This role ensures compliance with HealthcareQMS, regulatory standards (Health Canada, GDP/GMP, ISO), and client requirements while driving quality performance, audit readiness, and operational excellence.

Requirements

  • Post-secondary education in Quality, Life Sciences, Supply Chain, or related field
  • 1-3+ years of experience in quality assurance within healthcare, pharmaceutical, or regulated logistics environments
  • Knowledge of GDP/GMP, ISO standards, and Health Canada requirements
  • Experience with audits, CAPA, and document control systems
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint)

Nice To Haves

  • Familiarity with QIS, Vaisala, Valid aide, or similar systems is an asset

Responsibilities

  • Support the development, implementation, and maintenance of the QMS in alignment with DSV Canada and HealthcareQMS standards
  • Ensure compliance with regulatory requirements (Health Canada, GDP/GMP, ISO), client expectations, and internal procedures
  • Implement the site-level QMS structure and support multi-site quality initiatives
  • Conduct process audits and self-inspections; identify gaps and provide recommendations
  • Prepare for, support, and host internal/external/client, and regulatory audits
  • Track and support CAPA development, implementation, and closure
  • Manage quality events including deviations, change controls, complaints, returns, and recalls (including mock recalls)
  • Maintain and control quality documentation (SOPs, logs, records) ensuring accuracy, compliance, and version control
  • Act as Site Document Control Administrator and manage records within the Quality Information System (QIS)
  • Ensure proper document retention, accessibility, and audit readiness
  • Monitor key operational quality processes including temperature control, mapping, sensors, sanitation, pest control, and equipment records
  • Review and analyze data (e.g., Sensitech, Vaisala, ValidAide) to identify trends and drive improvements
  • Support validation and qualification activities (IQ/OQ/PQ)
  • Apply risk-based methodologies (e.g., FMEA) to quality processes
  • Analyze KPIs and quality data to identify improvement opportunities
  • Partner with operations and cross-functional teams to ensure effective quality system implementation
  • Lead Quality Improvement Team (QIT) meetings, manage action plans and promote quality initiatives
  • Support supplier/vendor qualification, onboarding, and compliance
  • Assist with customer onboarding, audits, and quality-related inquiries
  • Coordinate and track employee Quality training in collaboration with Human Resources and Training teams
  • Maintain accurate training and quality records
  • Provide administrative support for quality documentation, reporting, and compliance tracking

Benefits

  • eligible benefits
  • very generous benefit package
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