Remote Otter LogoRemoteOtter

Senior Quality Systems Specialist - Remote

Posted 10 weeks ago
QA
Full Time
USA

Overview

The Senior Quality Systems Specialist plays a key role in operating and maintaining our Quality Management System to support the development of digital therapeutics in compliance with international and US medical device regulations.

In Short

  • Join a remote-first company focused on mental health solutions.
  • Drive design control activities for SaMD products.
  • Support risk management and quality system processes.
  • Collaborate with cross-functional teams on quality management.
  • Facilitate compliance with ISO 13485 and FDA regulations.
  • Participate in internal and external audits.
  • Provide Document Control support within the eQMS system.
  • Work in an innovative environment backed by leading investors.
  • Enjoy a flexible working arrangement with competitive salary packages.

Requirements

  • A minimum of 3 years of Quality Management experience in medical devices.
  • Knowledge of 21 CFR 820, ISO 13485, and related regulations.
  • Experience in software development tools and Agile practices.
  • Strong communication skills and cross-functional experience.
  • BA/BS degree in a technical field or equivalent experience.

Benefits

  • Generous vacation policy.
  • Professional development fund.
  • Flexible working arrangements.
  • Competitive salary packages including stock options.
BigHealth logo

BigHealth

Big Health is a pioneering digital health company dedicated to improving mental health through innovative, non-drug therapeutic solutions. With a mission to help millions regain good mental health, Big Health offers FDA-cleared digital therapeutics such as SleepioRx for insomnia and DaylightRx for anxiety, as well as the Spark Direct program for managing depressive symptoms. The company collaborates with leading healthcare organizations, including Fortune 500 companies and Scotland’s NHS, to design the future of mental health care. As a remote-first organization, Big Health emphasizes diversity, equity, and inclusion, aiming to reflect the communities it serves while providing a supportive work environment with competitive benefits.

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