System & Support Quality Assurance Engineer

Responsibilities

• Manage supplier quality by planning, organizing, and conducting audits of systems, processes, and products
• Ensure compliance with GMP requirements and regulatory standards
• Manage quality events including Change Control, CAPA, and deviations
• Implement effective containment actions and resolve non-conformities
• Document and report audit results and collaborate with departments to close gaps
• Monitor and evaluate service performance
• Provide training and coaching on quality systems and regulatory compliance
• Support product development and participate in document management

Requirements

• Bachelor's degree in a scientific field, engineering, or an equivalent discipline
• Minimum 2 years of experience in Quality Assurance, ideally within the biomedical or pharmaceutical industry
• Strong knowledge of quality audits and regulatory standards
• Technical proficiency, including the ability to read and understand technical plans and standards
• Excellent organizational skills with a high level of attention to detail
• Strong communication skills for professional representation of the company
• Fluency in English (both written and oral)

About the Company

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We are a global biotechnology service provider dedicated to advancing cell culture and innovative cell therapies.