Quality System & Compliance Specialist

Grifols

Quality System & Compliance Specialist evaluating materials and suppliers within Grifols' healthcare division. Ensuring regulatory compliance and aiding in quality system processes in Montreal.

Posted 6/4/2026full-timeMontreal • 🇨🇦 CanadaMid-LevelSeniorWebsite

ATS Keywords

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Hard Skills

quality systemssupplier quality managementGood Manufacturing Practices (GMP)risk assessmentsSOP drafting and reviewCAPAchange controlsquality system improvementsregulatory compliancetechnical guidance

Soft Skills

written communicationverbal communicationintegrityprofessional rigorcollaboration

Certifications & Qualifications

Bachelor's degree in STEM

Industry Keywords

regulatory requirementsHealth CanadaFDA CFRinternal auditssupplier auditsquality controlmaterials evaluationapproved supplierscustomer auditsdepartmental safety procedures

About the role

Key responsibilities & impact

Evaluate materials and suppliers in accordance with established procedures.
Ensure materials comply with specifications, regulatory requirements, and internal standards.
Produce and review product evaluation reports.
Conduct annual evaluations of qualified suppliers based on quality, compliance, and performance criteria.
Participate in risk assessments related to materials and suppliers.
Maintain the list of approved suppliers and ensure their ongoing compliance.
May participate in internal audits and supplier audits.
Provide support for regulatory inspections and customer audits, as required.
Support the management and continuous improvement of systems, programs, or projects related to quality.
Ensure compliance with company policies and procedures within the scope of expertise.
Provide technical guidance on quality and compliance matters.
Collaborate with manufacturing, regulatory, and production teams on GxP-related issues.
Adhere to Good Manufacturing Practices (GMP) and departmental safety procedures.
Assist in preparing proposals and recommendations for department management.
May investigate and resolve quality issues related to materials and suppliers.
Draft and review SOPs and other quality documents related to materials and suppliers.
Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPA, change controls, and quality system improvements.

Requirements

What you’ll need

Bachelor's degree in Science, Technology, Engineering, or Mathematics (STEM) or equivalent experience.
Minimum of 5 years' relevant experience in quality.
Demonstrated experience with quality systems and supplier quality management.
Excellent written and verbal communication skills.
Strong understanding of applicable national (e.g., Health Canada) and international (e.g., FDA CFR) regulatory requirements and guidelines.
High level of integrity and professional rigor.
Bilingual in French and English required.

Benefits

Comp & perks

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