Spécialiste des systèmes de qualité/Quality Systems Specialist
Core
Ensures quality initiatives and compliance objectives for facility methods, procedures, validations, and quality planning across existing and new product designs.
Role type
Quality Systems Specialist (Manufacturing/Pharma)
Builds
Quality plans, validation protocols, CAPA, and compliance reports for manufacturing systems.
Domain
Pharmaceutical/Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control, validation protocols (IQ/OQ/PQ), root cause analysis, CAPA management, regulatory compliance (Health Canada/FDA/cGMP), metrology management, risk assessment, laboratory analysis
Preferred skills
Professional quality certifications (CQE/CQA/CQM/RAB), bilingualism (French/English), organic chemistry/microbiology lab experience
Technologies
SAP, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Develop and improve facility quality plans and manufacturing processes; investigate product complaints and prepare reports; analyze data to identify failure causes and recommend corrective actions; draft and review validation protocols and quality system procedures; manage metrology programs and calibration activities; participate in internal and external audits; support product design control and risk assessments; provide in-house training on quality topics.
Seniority
Entry to Mid-level, hands-on IC
