Quality Management System Engineer

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