Starling
AI enabling digital urine diagnostics in the home
Director of Quality
About the role
At Starling we're bringing the future of a proactive and predictive home-based healthcare system to patients today.
In the US, 80% of healthcare spend occurs in 20% of patients. We aim to drastically reduce this cost through modern software, hardware, and preventative care services. Our core device, the UrinDx, combines continuous urinary diagnostics and machine-learning to allow patients to track changes in their health at home by monitoring changes in their urine over time.
To date, we've raised from top tier investors such as Y Combinator, Innospark Ventures, Rebel Fund, and some of the largest strategics in the space.
Starling Medical is looking for a Medical Device Quality Management System (QMS) expert who is passionate about all things ISO 13485.
Responsibilities include, but may not be limited to:
- Maintain all controlled documents and revisions according to the QMS.
- Provide management and oversight to the QMS that is compliant with ISO 13485 and 21 CFR 820 for products on the market and new products in development.
- Coordinate with manufacturers and suppliers to ensure compliance with the Starling QMS and the necessary regulatory bodies.
- Achieve quality goals through planning, coordinating, and supervising quality activities.
- Develop corrective action plans for non-conformances and develop process improvements.
- Lead Verification & Validation efforts for implemented products on the market and new products in development.
- Lead process validation and implement supplier agreements which ensure quality standards that extend to our partners and vendors.
- Discuss inspection results with those responsible for products and recommend necessary corrective actions.
- Oversee internal and external quality audits.
- Maintain calibration standards on all relevant measurement and test equipment.
Experience working with post-production medical devices systems, including manufacturing, is required.
Experience with integrated hardware/software medical devices and use of an eQMS platform is recommended.
About Starling
At Starling we're bringing the future of a proactive and predictive home based healthcare system to patients today.
In our vision, we will identify and predict chronic health exacerbations of patients earlier at home so we can activate preventive care measures in an non-emergent setting vastly improving outcomes and costs for the whole system.
Our team of serial entrepreneurs, engineers, and clinicians are building the next generation of medical products at the intersection of hardware, software, and artificial intelligence. We develop these next generation products to improve the lives of chronic care patients by passively monitoring changes in their urine over time with our AI and care team infrastructure.
