Quality Management System Engineer

Job Summary

A company is looking for a Quality Management System Engineer.

Key Responsibilities

• Design, implement, and maintain a functional Quality Management System (QMS) for the Flow Cytometry division
• Engage in the development and maintenance of critical validation documentation
• Serve as the technical subject matter expert during the sales cycle and facilitate successful audits

Required Qualifications

• 7+ years in the Biopharma/MedTech space, with at least 5 years focused on Computer System Validation (CSV) and Quality Management for SaaS
• B.S. or Advanced Degree in Life Sciences (Immunology/Hematology preferred) or Computer Science
• Deep understanding of Flow Cytometry data analysis workflows
• Proven track record of navigating regulatory requirements such as 21 CFR Part 11 and ISO standards
• Ability to balance technical and strategic responsibilities effectively