Director of Quality

About Hello Heart:

Hello Heart is the only digital therapeutics company to focus exclusively on heart disease, the leading cause of death for U.S. adults. Through a connected device and mobile app that uses AI, behavioral science, and personalized digital coaching to drive lifestyle changes, Hello Heart empowers people to embrace healthier behavior, which can reduce the risks of high blood pressure and heart disease. It also helps users catch blood pressure readings that are extremely high and encourages them to talk to their doctor to identify potential risk in time. Validated in peer-reviewed studies and trusted by leading Fortune 500 companies, Hello Heart is easy to use and works alongside an employer’s benefits ecosystem. Founded in 2013, Hello Heart is a member of the American Heart Association’s Innovators’ Network and is part of the CVS Health Point Solutions Management program. Hello Heart is backed by leading VCs including Stripes, Khosla Ventures, IVP, Blue Run and Resolute. Visit www.helloheart.com for more information. 

About the role:

As Director of Quality you’ll be responsible for building Hello Heart’s quality system, in compliance with FDA regulations and international standards.  We need a creative, collaborative, and proactive partner who will deeply understand our manufacturing processes – for software and hardware – and will use a risk-based approach aligned with Hello Heart’s fast-paced and user-focused culture to implement appropriate policies and procedures.  

Responsibilities:

• Design and build a quality system consistent with ISO 13485:2016, compliant with 21 CFR Part 820, and other applicable regulatory requirements, partnering with internal stakeholders in a user-focused, fast-paced environment.
• Act as Quality Management Representative for quality system certifying bodies[AY1] 
• Collaborate with product development teams, taking a lead role in quality/design assurance.
• Lead the supplier management program, ensuring suitable evaluation and control of supplier operations affecting product quality. Conduct audits at critical suppliers to ensure compliance with specifications and applicable regulatory requirements
• Lead the establishment of a quality culture, educate the company on the importance of a quality system for achieving our mission and goals; communicate effectively to ensure each individual understands their role
• Ensure inspection readiness of the QMS, and host external audits and inspections as necessary
• Undertake special projects to support regulatory and compliance program initiatives[AY2] 
• Become a trusted, go-to advisor who advances the company’s overall mission and goals 
• Remain up-to-date on relevant industry trends, laws, regulations, guidance, and standards to ensure ongoing compliance

Qualifications

Basic Qualifications:

• 8+ years of experience building and/or implementing medical device quality systems aligned with ISO 13485 and 21 CFR Part 820, specifically including design control, design assurance, IDE, and supplier management experience; experience with quality systems for both software as a medical device and traditional medical devices strongly preferred
• BS/BA in a scientific discipline or related field; data science or software engineering background a plus
• Solid judgment in identifying risks, developing solutions, and implementing successful strategies to mitigate risk while achieving the organization’s commercial goals.  
• Experience with ISO 14971 strongly preferred.
• Highly organized, strong project management skills, with the ability to handle multiple initiatives and tasks simultaneously in a entrepreneurial, dynamic environment
• Growth-minded, with demonstrated ability to rapidly absorb and internalize new information and processes
•  Excited to conceptualize and build key capabilities and processes at rapidly growing startup, with strong change management skills
• Excellent oral and written communication skills, highly effective in a distributed environment
• Ability to travel occasionally

Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.