Quality Assurance Specialist - AI Medical Devices

We are seeking a motivated Quality Assurance Specialist to lead quality and compliance across Hyfe's product portfolio. This role offers an exciting opportunity to work at the forefront of AI-powered digital health technology.

Your Mission

As Hyfe's Quality Assurance Specialist, you'll be the guardian of quality and compliance for Hyfe's AI-driven healthtech products, including two innovative medical devices. Partnering closely with our Head of Regulatory and Quality, you´ll lead quality initiatives, oversee compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 27001, and collaborate with cross-functional teams to integrate quality at every stage of development and production. Your expertise will be key in fostering a culture of excellence throughout the company. This role will suit you if you’ve gained skills and expertise working on a team and you’re now ready to take on greater ownership.

Responsibilities

• Administer and elevate the Quality Management System (ISO 13485, ISO 27001)
• Deliver certification in ISO 13485 and ISO 27001
• Support the digital therapeutic team with development of Design Controls and Risk Management activities
• Develop and deliver engaging and impactful training for the Hyfe team
• Conduct internal audits and identify areas for continuous improvement
• Support global regulatory submissions beyond FDA (EU, PMDA, UK)
• Ensure Hyfe maintains our 100% success rate in passing new customer compliance audits

Must have

• 4+ years of experience in medical device quality assurance (must be medical devices, not pharma)
• Proven experience in implementing quality systems to ISO 13485
• Experience developing & implementing processes, not only executing existing processes
• Empathy for technical teams who want to work fast
• Experience thriving in a startup or small-team environment

Nice to have

• Experience with Jira, Confluence and SoftComply
• Experience with 21 CFR 820 and ISO 27001
• Experience in software validation & qualification (product & QMS)
• Auditing experience
• Technical skills, coding abilities

About Hyfe

Hyfe, Inc. is the global leader in AI-powered cough-monitoring technology. Our patented machine-learning software enables passive, long-term monitoring of cough frequency, unlocking novel health insights. Hyfe delivers cough-monitoring solutions that empower pharma and academic researchers to advance clinical trials, enable healthcare providers to optimize patient care, and power digital therapeutics to transform the management of respiratory illness, including chronic cough. Our technology has been used in 50+ research studies in partnership with leading global pharma companies and academic institutions. Discover more at hyfe.com.

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