Quality Manager (Temp)

| Santa Monica | Remote
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About the Quality Manager at Headspace:

Headspace exists to improve the health and happiness of the world, and we are expanding our capabilities to deliver on that mission. We are in search of an extraordinary quality management leader who wants to help build and grow a new mental health initiative within a leading digital wellness organization. The ideal candidate has significant experience working within a regulated medical device organization, with exposure to digital therapeutics. This individual will be responsible for leading the development of and maintaining quality systems and providing support for Headspace in key areas such as new product development and system compliance. We are looking for a go-getter who is not afraid to put in the time and effort to develop, build, and implement a best-in-class quality management program from the ground up, as well as advocating for the broad adoption of product quality standards across the organization.

The Quality Systems Lead will join a cross-functional team reporting to the Director of Behavioral Science. This individual will be a key member of the leadership team responsible for building new mental health products and services for our business-to-business (B2B) customers. This is a temporary, project-based role with the potential to transition to a permanent position after three months.

Location: This role is open to remote employees in select US states: California, New York, Florida, Georgia, Texas, Maryland + Washington DC, North Carolina and Washington. 

How your skills and passion will come to life at Headspace:

  • Provide Quality System Body of Knowledge expertise and support to our organization
  • Ensure compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements
  • Serve as the organization's quality liaison to third party vendors and customers
  • Lead multifunctional teams in completing program directed or continuous improvement activities
  • Identify and implement data analysis, systems evaluation, and product assessment to ensure system conformance and ensure finished products meet standards and specifications; implement and drive changes where needed
  • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Lead and implement improvement methodologies and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying opportunities in quality system compliance, device, and process
  • Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Create a supportive, inclusive work culture while promoting the importance of quality management

What you’ve accomplished:

  • Bachelor's (Master’s Degree Preferred) in Engineering, a related technical Field or an equivalent combination of education and work experience
  • Previous Quality experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Prior medical device experience. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • 8+ years related experience, including 4 years of supervisory experience
  • Comfort working in an early- or mid-stage company; readily adaptable to changing market and organizational requirements
  • Solid communication and interpersonal skills. Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

How we feel about Diversity & Inclusion:

Headspace is committed to bringing together humans from different backgrounds and perspectives, providing employees with a safe and welcoming work environment free of discrimination and harassment. We strive to create a diverse & inclusive environment where everyone can thrive, feel a sense of belonging, and do impactful work together. As an equal opportunity employer, we prohibit any unlawful discrimination against a job applicant on the basis of their race, color, religion, gender, gender identity, gender expression, sexual orientation, national origin, family or parental status, disability*, age, veteran status, or any other status protected by the laws or regulations in the locations where we operate. We respect the laws enforced by the EEOC and are dedicated to going above and beyond in fostering diversity across our workplace. 

*Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Headspace. Please inform our Talent team if you need any assistance completing any forms or to otherwise participate in the application process.

How to get started:

If you’re excited by the idea of seeing yourself in this role at Headspace, please apply with your CV and a cover letter that best expresses your interest and unique qualifications.

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Location

We're located in the heart of Santa Monica on Michigan + Cloverfield, just off the 10 freeway. Bergamont train station is right behind our office.

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