Senior Quality Systems Auditor
Help Us Build the Future of the Human Heart.
At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.
About the Role
We are seeking an experienced QMS Internal Auditor to plan, execute, and report on internal quality system audits in accordance with ISO 13485:2016, 21 CFR Part 820, and FDA IDE requirements. This individual will serve as a key contributor to BiVACOR's ISO 13485 certification readiness program and ongoing QMS surveillance activities, reporting directly to the Director of QA & Regulatory Affairs.
Key Responsibilities: Audit Planning & Execution
Develop and maintain the annual internal audit schedule based on risk, regulatory requirements, and process criticality.
