Flok Health is seeking a Quality Assurance Engineer with a software background to enhance our medical device development tools and processes. This role is pivotal for ensuring compliance with regulatory requirements and optimizing workflows.
As the first dedicated Quality Assurance and Regulatory Affairs Engineer at Flok Health, you'll play a vital role in shaping our procedures. This position demands a user-centric approach and collaboration across different teams, including clinical and product engineering. Your responsibilities will include improving processes, ensuring compliance with ISO standards, and supporting our engineers in maintaining technical documentation.
Key Responsibilities:
• Know and apply relevant ISO standards like 13485 and 62304
• Design and implement improvements for regulatory processes




• Collaborate with teams to enhance efficiency and reduce overhead
• Develop internal tools to streamline organizational processes
• Assist in managing technical file documentation for medical devices
Requirements:
• Exposure to software-as-medical-device development
• Robust understanding of ISO standards and regulatory processes
• Ability to work collaboratively in a small team
• Eager to learn and take on significant responsibilities
• Commitment to driving process improvements and compliance
Harness your engineering skills to make a significant impact on healthcare solutions at Flok Health.
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📌 Quality Assurance Engineer At Flok Health Cambridge
🏢 Foundation Partners
📍 Cambridge