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Quality Assurance and Regulatory Affairs Manager

About us:

At Myant, we are creating the world’s first textile computing platform, integrating technology directly into the only thing we’ve been wearing our entire life – clothing. SKIIN is our first consumer facing brand, and SKIIN’s vision is to enhance human ability through connected clothing - think Ironman’s suit, but comfortable. The sensors and actuators embedded within our apparel create your Digital Identity, which will be consumed by those who matter to you - your family members, doctors, coaches, other IoT devices - without you consciously having to think about it. Imagine a world where you walk into your house and the temperature automatically adjusts to your optimal body temperature, the lights adjust to your mood, or your doctor is aware of the onset of a disease before you even visit. The line between the digital and physical world is becoming increasingly blurry, and we believe textile is the next medium to bridge that gap.

We’re looking for people who believe in our mission to make wearable technology truly ubiquitous and convenient, so that everyone can benefit from it. We are a cross-functional team solving big challenges at the intersection of fashion, electronics, software, and data science.



This individual will contribute to the entire process for ISO certification and FDA approval for Myant produced products. You will take pride and ownership over your work, be a critical voice during process review and development, and challenge manufacturing procedures and quality assurance.



  • Managing the process for the implementation and documentation required for ISO 13485 certification
  • Managing the process for the implementation and documentation required for ISO 16949 certification
  • Creating, maintaining documentation, protocols, and coordinating test results for FDA approval, 510(K) submission
  • Coordination with team leads from all areas of manufacturing and engineering



  • A bachelor or master’s Degree in Science, Engineering or Biomedical
  • 5+ years hands-on QA experience, minimum two years of managing projects or teams
  • ISO 13485 medical device; standards & guidelines
  • ISO 16949 automotive, standards and guidelines
  • ISO 14001 environmental, standards and guidelines
  • FDA approvals for wearable technology medical devices
  • Previous experience in an entrepreneurial work environment
  • Certification for quality audit, quality engineer, and quality improvement
  • Knowledgeable in process, engineering, software validation requirements; protocols & testing
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