Quality & Compliance Manager

About HealthRhythms 

At HealthRhythms, our mission is to alleviate unnecessary suffering by bringing mental health into the modern era of medicine. We have combined the multi-dimensional sensing capabilities of mobile phones with the power of embedded and cloud computing platforms and novel AI algorithms to continuously measure mental health status. We are realizing the vision of precision medicine for mental health by anticipating deterioration of mental health and delivering personalized, just-in-time interventions.

We have built and tested this platform with $7M of NIH funding and are commercializing with a dual-track focus on pharma and US payors. Based on the elite quality of the team, the empirical evidence, and the innovation itself, we have closed a highly over-subscribed $11M seed financing with 36+ top Silicon Valley health tech and healthcare investors. Brook Byers (Kleiner) personally co-anchored the round with GSR Ventures ($3B health tech).

If joining an accelerating, 100% remote startup that is trying to significantly improve people’s lives sounds meaningful and exciting to you, please read on and apply. 

As Quality & Compliance Manager, you will:

• Develops, improves, and monitors Quality Systems for the entire organization.
• Oversees and maintains the CAPA, including investigation, root cause analysis, corrective actions, and effectiveness verification, to drive continuous improvement and prevent recurrence of quality issue
• Provides direction and oversight during active processes and applies understanding of FDA regulations, FDA Quality Systems and Continuous improvement, and ensures ongoing compliance for HIPPA, SOC-II and other qualifications as needed.
• Build and train on existing quality documentation, processes, and workflows
• Research new quality assurance methods relevant to emerging technology.
• Collaborate with project teams to implement effective processes
• Coordinates and conducts internal audits to assess compliance with quality standards, regulatory requirements, and QMS procedures
• Fosters a culture of quality throughout the organization by promoting awareness, accountability, and continuous improvement in quality processes and practices

You have the following required experience:

• 5-7 years of QMS and Compliance experience within the healthcare technology/ medical device space.
• ASQ/CQE (certified quality engineer) certification a plus 
• Prior experience  auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits.
• Experience in managing CAPA processes, conducting investigations, performing root cause analysis, and implementing corrective and preventive actions.
• Experience understanding, interpreting, and applying laws and regulations and change management 
• Strong analytical skills and attention to detail, significant experience with QA and compliance methodologies and standards, and ability to create and evaluate data and statistical information.

What we value? 

• Mental health as foundational to overall health.
• Protecting patient privacy at all costs. We actively develop privacy protective algorithms to ensure that only clinically relevant information is recorded. 
• Creating person-specific interventions driven by Machine Learning that dynamically adapt and scale, yet remain personal
• Deploying empirically-validated approaches to measuring and improving mental health 
• Empathically supporting people in becoming more active, socially engaged, and above all more mentally healthy

We value passion in people to transform how mental health is considered in society

We're looking forward to hearing from you!

We believe that diversity makes us better: we welcome people from all backgrounds.

HealthRhythms is a Social Impact Organization

The unmet need: In contrast to all other areas of medicine, up until now mental health has been largely reliant on subjective patient self-report. This contributes to reduced quality of care and poorer treatment outcomes, leading to higher dropout rates, ER visits, hospitalizations, etc. Mental health clinicians need objectives, continuously collected and easily interpretable patient data to fully appreciate patient status and enable quick, flexible, and targeted interventions. Patients and families need information that can help them to manage their own illness in a more effective manner. 

HealthRhythms is on a mission to become the world leader in objectively measuring mental health. We