Spécialiste, système qualité & conformité Matériaux Quality System & Compliance Specialist Materials

GRIFOLS, S.A.•Montreal, QC

1d•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Titre du poste : Spécialiste, système qualité et conformité (Matériaux) Relève de : Superviseur, système qualité et conformité - Matériaux Résumé : Le spécialiste, système qualité et conformité – matériaux, contribue activement à l’évaluation et à la qualification des matériaux et des fournisseurs au sein du département Système qualité et conformité. Il apporte une expertise technique dans le cadre de projets, d’audits et d’activités de conformité, tout en assurant le respect des exigences réglementaires et des normes internes. Il participe à la collecte et à l’analyse de données afin d'aider le département à prendre des décisions et peut participer à la formation technique et non technique. D'autres tâches peuvent lui être assignées selon les besoins. Summary: The Specialist, Quality System & Compliance – Materials and Suppliers plays a key role in evaluating and qualifying materials and suppliers within the Quality System and Compliance department. This individual provides technical expertise in support of projects, audits, and compliance activities, ensuring adherence to regulatory requirements and internal standards. The specialist contributes to data collection and analysis to support departmental decision-making and may assist in delivering technical and non-technical training. Additional tasks may be assigned as needed.

Requirements

Bachelor’s degree in a STEM field (Science, Technology, Engineering, Mathematics) or equivalent combination of education and experience.
Minimum of 5 years of relevant experience in quality systems.
Demonstrated experience in supplier quality management and material qualification.
Strong written and verbal communication skills.
Solid understanding of applicable national (e.g., Health Canada) and international (e.g., FDA CFR) regulatory requirements and guidelines.
High level of integrity and professionalism.
Bilingual in French and English (la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA)

Responsibilities

Perform evaluation of materials and suppliers according to established procedures. Ensure materials meet specifications, regulatory requirements, and internal standards. Generate and review commodity evaluation reports.
Perform annual evaluation of qualified suppliers based on quality, compliance, and performance criteria.
Participate in risk assessments related to materials and suppliers.
Maintain the approved supplier list and ensure ongoing compliance.
May participate in internal and supplier audits.
Support regulatory inspections and customer audits as needed.
Support the management and continuous improvement of quality systems, programs, or projects.
Ensure compliance with company policies and procedures within the scope of expertise.
Provide technical guidance on quality and compliance-related matters.
Collaborate with manufacturing, regulatory, and production teams on GxP-related issues.
Adhere to GMP and departmental safety practices.
Assist in preparing proposals and recommendations for the department’s leadership.
May investigate and resolve quality issues related to materials and suppliers.
Draft and revise SOPs and other quality documents related to materials and suppliers.
Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPAs, change controls, and quality system improvements.