Job description
The Technical FDA Writer is responsible for authoring, revising, and maintaining the controlled documentation that underpins MMO's Quality Management System (QMS). This role owns the drafting and revision of Standard Operating Procedures (SOPs), Work Instructions (WIs), Playbooks (PBs), forms, and supporting quality documentation used across MMO's operational sites in support of FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016 compliance.
This role works cross-functionally with Quality, Operations, IT, and customer program owners to translate regulatory requirements and operational realities into clear, defensible, audit-ready documentation.