Quality Manager

United States /
Regulatory Affairs and Quality Assurance /
Full-time
At Sirona Medical we’re building tools for physicians to work as fast as they can think.  Many billions of patient images are acquired each year in the U.S., and nearly all of them are reviewed and diagnosed by a radiologist. In fact, 80% of healthcare data flows through radiology IT systems, and radiologists are among healthcare’s most tech-savvy and influential physicians. But they desperately need better, user-friendly software that cuts clicks and optimizes diagnostic time. Sirona is building a modern cloud-native and AI-powered operating system (“RadOS”) that unifies radiology IT onto a single, streamlined workspace. We’re a San Francisco, CA-based software company (with employees working from all over the U.S.) founded on a deep understanding of both the practice and business of radiology. 

For more information, please visit www.sironamedical.com.

The Quality Manager at Sirona is responsible for refining and executing the Quality System Company-wide. All company activities are in scope. The Quality Manager will work with each  Sirona team to bring the next generation of medical imaging software to the market, with demonstrable quality levels as a Competitive differentiator.

Responsibilities

    • Development of Quality strategy for existing and new product pipeline to include AI/ML functionality
    • Support preparation and execution of regulatory actions including registration with Regulatory personnel and pre-sub, 510(k), PMA, CE mark with the VP, Regulatory Affairs and Quality
    • Participate in planning and communication of clinical trials process to support regulatory submission
    • QMS and lean, cost-effective quality processes
    • Quality metrics, trending, corrective and preventive plans
    • Work closely with each team, ensure the QMS is adopted evolving as appropriate
    • Support post-marketing surveillance
    • Manage and own quality audit plans and execution, follow-up
    • Work with product and customer success teams to maintain a culture of quality and excellence
    • Support Patient privacy compliance including HIPAA and SOC 2

Requirements

    • 5 years successful software industry experience, preferably in the medical device field
    • Experience with software quality management
    • Awareness of quality standards: ISO 9001, ISO 13485
    • Prior experience in startup environment a plus
    • Excellent organizational and communications skills
    • Ability to grow into new capabilities
    • Ability to drive change cross-functionally
    • Strong motivation to meaningfully advance healthcare technology while enhancing patient safety

Benefits

    • Unlimited PTO
    • Medical, dental, vision insurance
    • Life insurance
    • Maternity and Paternity Leave
    • 401K matching
    • Apple equipment
    • Sponsorship for conferences, continuing education, etc.
    • #LI-remote