Quality Assurance Manager for Medical Devices

1 week ago


Copenhagen, Copenhagen, Denmark Corti Full time

Join our team at Corti as we work together to revolutionize the dialogue in healthcare. As a Compliance and Risk Management Lead, you will be responsible for ensuring our products and services meet the highest standards of quality and compliance.

About the Company

Corti has built the world's premier AI assistant for healthcare providers. It listens in during patient dialogue, takes notes, writes summaries, journals, and does quality assurance. When information is missed, or risk is high, it offers nudges and prompts to help steer the dialogue back on the right path.

Key Responsibilities
  • Develop and implement quality management systems to ensure compliance with relevant regulations and standards.
  • Assess and mitigate risks associated with medical device development and deployment.
  • Create technical documentation to support regulatory submissions and internal audits.
  • Support the VP of Governance and Market Access in implementing best practice methods and standards.
Requirements
  • Bachelor's degree in a relevant field required; Master's degree preferred.
  • A minimum of 2 years of experience in quality management, risk management, and medical device regulation.
  • Familiarity with industry regulations and standards related to medical devices, quality management, and risk assessment.
  • Excellent verbal and written communication skills.
  • Prior experience in conducting risk assessments, developing risk mitigation strategies, and implementing risk management frameworks.


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