Quality Assurance Associate

Responsibilities

• Review and ensure compliance of the Quality Management System with Canadian GMP, ISO 13485, and Canadian Medical Device Regulations.
• Identify, document, and manage the closure of Corrective and Preventive Actions (CAPAs) to drive continuous improvement.
• Ensure on-site documentation complies with quality systems for stability and product release, including monitoring temperature reports.
• Conduct product release activities and manage the release of returned restockable products.
• Perform revisions to SOPs, forms, and processes to streamline systems and ensure GMP/GXP compliance.
• Support the local Supplier Qualification process and manage quality agreements and vendor deviations.
• Maintain on-site quality records, including stability, validation, and traceability records.
• Support internal audits and perform annual product reviews according to defined schedules.
• Coordinate activities related to the qualification and validation of GMP equipment.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience (or high school +8 years; Associate degree +4 years).
• Fluency in reading, writing, understanding, and communicating in English.
• Knowledge of GMP and ISO 13485 standards.

Benefits

• Robust benefits package including health, life, and retirement plans.
• Paid time off.
• Opportunity to work in a highly collaborative and diverse environment.

About the Company

Alcon is the global leader in eye care, dedicated to helping people see brilliantly. We develop and manufacture innovative devices and solutions across the full life cycle of eye care needs, from surgical equipment to consumer contact lens solutions. Founded in 1945, Alcon operates in 180 countries worldwide, driven by a mission to enhance sight and improve lives.