About Scanwell

Scanwell Health is an app that turns your smartphone into a clinical lab. By pairing traditional lab tests with computer vision technology, we make it possible to test from the safety of home and get instant results without having to send samples back to a lab. Our technology helps healthcare organizations provide better virtual care and improves access to diagnostics in low- and middle-income countries. Most recently, we’ve partnered with global medical technology company BD to power at-home testing for COVID-19.

Scanwell is looking for a Quality Compliance Specialist to join our Regulatory team. The Scanwell Quality Compliance Specialist will ensure compliance with applicable QA systems (FDA/ISO/HIPAA ). They will report to the Regulatory team but work closely day-to-day with management and individuals of other groups (Engineering, Design, etc.) to ensure appropriate compliance.

About the job

As a Quality Compliance Specialist, you’ll be responsible for:

  • Ensure quality compliance with FDA regulations and ISO standards
    • CAPAs, complaints, deviations, document control, change control, AVL, risk assessments, authoring/editing SOPs and WIs, training.
  • Ensure quality product development
  • Review and analyze specifications
  • Ensure adequate testing strategies and test plans
  • Work with expert QA/RA consultants to author company SOPs and all associated QA documents
  • Author/edit SOPs and WIs, document control, change control, AVL, training
  • Writing regulatory assessments for product updates
  • Performing complaint MDR assessments
  • Managing MRDs / Vigilance
  • Enforce and manage compliance with the company SOPs

What we’re looking for

  • 3+ years of QA experience in FDA QSR and ISO compliance, five years preferred
  • 1+ years of QA decision-making experience, three years preferred
  • Familiarity with software development life cycle preferred
  • A keen and working understanding of 21 CFR 820, ISO 13485, ISO 14971, IEC 62304
  • A team player
  • Excellent communication and public speaking skills

Bonus points for

Previous startup experience

Experience in healthcare, medical devices, or related industries

Benefits

  • Remote company
  • Medical, dental, and vision insurance
  • HSA with match
  • 401k with up to 4% company match
  • Generous paid time off policy
  • Charitable donation matching
  • Stipend for home office setup and food delivery

Scanwell Health is committed to having a workforce that is reflective of the diversity within the United States. As an equal opportunity employer, we encourage applications from candidates from underrepresented communities, Indigenous persons, persons with disabilities, persons of diverse sexual orientation and gender identity, and all those who can provide different perspectives and contribute to the diversification of Scanwell Health.