Job Description
Job Overview
As Quality & Compliance Manager , you will lead and oversee the Quality Management System (QMS) across three US entities, ensuring harmonization while maintaining compliance with FDA, ISO 13485, and applicable federal and state regulations governing medical device and pharmaceutical distribution activities.
This role defines and executes the regional quality and compliance strategy, serves as the US Management Representative and primary liaison with regulatory authorities, and ensures that products released to the US market meet all regulatory and quality requirements. The position drives continuous improvement, audit readiness, effective corrective and preventive actions, and provides leadership to the quality team to sustain best‑in‑class compliance performance.
Responsibilities
- Set the organizational and compliance strategy for the QA organization in the US in collaboration with the Zeiss Global Quality team.
- En...