Spécialiste, système qualité & conformité Matériaux Quality System & Compliance Specialist Materials
On-site · Montréal, Quebec, Canada
Job Summary
Specialist, Quality System & Compliance – Materials contributes to evaluating and qualifying materials and suppliers within the Quality System and Compliance department. Provides technical expertise for projects, audits and compliance activities, ensures regulatory and internal standard adherence, collects and analyzes data to support decisions, and may assist in training. Responsibilities include evaluating materials and suppliers against specifications and regulatory standards, maintaining the approved supplier list, participating in internal and supplier audits, supporting regulatory inspections and customer audits, driving continuous improvement of quality systems, drafting and revising SOPs and quality documents, collaborating with manufacturing, regulatory and production teams on GxP issues, ensuring GMP compliance, and assisting with CAPAs and change controls. Qualifications include a STEM degree or equivalent experience, at least 5 years in quality, supplier quality management experience, strong communication skills, knowledge of Health Canada and FDA CFR guidance, high integrity, and bilingual French/English.
Required Qualifications
- Bachelor’s degree in STEM or equivalent
- Minimum of 5 years of relevant quality experience
- Experience in supplier quality management and material qualification
- Strong written and verbal communication skills
- Knowledge of national and international regulatory requirements (e.g., Health Canada, FDA CFR)
- Bilingual in French and English
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