Job Description
Position Overview
The Site Head, Quality is a critical member of the senior leadership team at Outset Medical’s Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory standards. This role drives quality excellence in the production of Class II medical devices (hemodialysis systems and consumable cartridges), ensuring patient safety and scalability to meet growing market demand.
Key Responsibilities- Develop and execute quality strategies that align with Outset Medical’s growth objectives, ensuring scalable manufacturing processes while prioritizing patient safety and regulatory compliance.
- Lead and mentor a team of 12-15 quality professionals, fostering hands‑on collaboration, professional development, and a culture of accountability in daily operations.
- Oversee all QA functions at the manufacturing site, including incom...