At WHOOP, we're on a mission to unlock human performance. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives.

WHOOP is looking for a Director of Medical Quality Systems to establish a quality system in order to facilitate rapid SaMD development and commercialization. The person who fills this role will build and lead a new team to bring world-class quality management to WHOOP.

As the Director of Medical Quality Systems, you will be the first full time hire at WHOOP responsible for setting the vision, choosing the technologies, and implementing the system that will allow WHOOP to develop SaMD in a rapid, agile manner. In an innovative and evolving space, you will need to bring best practices and also creative problem solving with an ability to support high speed development. Additionally, you will act as the expert consultant within WHOOP for other teammates to learn and follow the policies and guidance you set.

RESPONSIBILITIES:

• Build and lead an organization to develop a quality management system within WHOOP and lead change-management efforts 
• Support and contribute to the overall strategic interest of WHOOP
• Lead by doing: Implement a quality management system by both directly contributing as well as leading a team.
• Mentor teammates and evangelize world-class quality management within WHOOP.
• Create and maintain a budget for the quality organization.
• Recruit a world-class team
• Work with other WHOOP team members in different departments as well as with outside regulatory consultants to ensure quality excellence and project success.
• Stay current with changes in the regulatory environment and provide guidance to the management team

QUALIFICATIONS:

• 6+ years of broad experience with quality systems, with at least 2 years as a senior leader with direct responsibility for a quality system.
• Deep understanding of quality system requirements (Part 820 and ISO 13485) and of common standards for software (ISO 62304).
• Demonstrated change-management experience.
• Proven ability to create a culture of accountability and ownership.
• Experience with SaMD and regulated software development is desired, but not required.
• Experience working with a small, agile team or in a startup environment is desired.

WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility