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Director, Quality Assurance (Digital Health) – Remote

Happify Health

This is a Full-time position in Phoenix, AZ posted December 23, 2021.

About Happify Health

Happify Health is a global software-enabled healthcare platform company.

We design and deploy software to help improve mental health, physical health, and well-being.

We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people.

The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.

Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers.

Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives.

About the Role

We are looking for a passionate and ambitious Quality Assurance Director to join us in the bold and transformational journey to improve mental health, physical health and wellbeing across the continuum of care.

The Quality Assurance Director will be focused on Quality Management System and Software as a Medical Device (SaMD) related processes ensuring that the Quality Management System complies with FDA, ISO 13485 and international medical device regulatory standards.

The Quality Assurance Director will drive strategic and operational collaboration with various teams.

Responsibilities

  • Lead the development, implementation and maintenance of Happify Quality Management System
  • Advise Executive Management on quality planning and continuous improvement programs
  • Identify compliance gaps and develop and execute strategies to close gaps in an efficient, technical, and compliant manner
  • Participate in organizational project teams throughout product definition, risk analysis, software development, and verification/validation activities
  • Oversee Quality Control department 
  • Perform other related duties as assigned

Qualifications

  • 7-10 years Quality Assurance Management experience in the Medical Device Industry
  • Expertise in SaMD (particularly Smartphone App)
  • Demonstrated ability to articulate risk to product quality and quality system compliance
  • Experience working and negotiating with regulatory bodies
  • Sound understanding of medical device standards including ISO 13485, ISO 14971, IEC 62304, ISO 27001, 21 CFR 820, and MDR
  • Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude
  • Strong people leadership ability with a focus on mentoring and developing talent
  • Ability to thrive in a fast-paced, technical, and mission-focused environment

Happify values candidates with different backgrounds, experiences, and perspectives.

We do not discriminate based upon ethnicity, age, gender identity and expression, sexual orientation, religion, national origin, socioeconomic status, disability, or veteran status.

Were committed to building a company that is an inclusive environment for all.

There have been cases of scams targeting candidates by individuals pretending to work at Happify.

We will never ask you to share financial information to participate in our recruiting process.

If you suspect that youve been contacted by a scammer, please consider filing a report with law enforcement. 

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