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 62304Design and implement improvements for regulatory processesCollaborate with teams to enhance efficiency and reduce overheadDevelop internal tools to streamline organizational processesAssist in managing technical file documentation for medical devicesRequirements:Exposure to software-as-medical-device developmentStrong understanding of ISO standards and regulatory processesAbility to work collaboratively in a small teamEager to learn and take on significant responsibilitiesCommitment to driving process improvements and complianceHarness your engineering skills to make a significant impact on healthcare solutions at Flok Health.#J-18808-Ljbffr

📌 Quality Assurance Engineer At Flok Health (Cambridge)
🏢 Foundation Partners
📍 Cambridge