Quality Management System Leader

Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: Caldera Medical requires a senior quality leader to serve as both the on-site Quality Lead for the Westlake manufacturing facility and the enterprise-wide architect and steward of the Quality Management System. As the company grows across multiple sites - including operations in Neuchâtel - maintaining a robust, harmonized QMS that meets ISO 13485, FDA QSR/QMSR, and EU MDR requirements is essential to regulatory standing, product quality, and market access. This role is critical to sustaining audit readiness, driving a culture of continuous improvement, and protecting the company's ability to scale into new markets and sites. Reporting to the Head of Quality, this individual will lead the site QA/QC team, own the corporate QMS, and serve as the primary interface with regulators and notified bodies. Duties and Responsibilities...