Senior Medical Quality Assurance Specialist

Senior Medical Quality Assurance Specialist

We are looking for a senior-level Medical Quality Assurance Specialist to take ownership of our Quality Management System and drive quality excellence across regulated medical software and systems. In this role you will work closely with product, engineering, regulatory, and clinical teams to ensure our practices align with FDA compliance, ISO 13485 expectations, and high standards of traceability and validation
.

You are a quality-focused technologist with proven experience in regulated environments. You enjoy both designing quality frameworks and implementing them
, and are able to work independently and collaboratively across disciplines. This position demands a strong understanding of quality management, software validation, risk analysis, traceability, and audit readiness.

This is the best way to gain experience and form a terrific community. 10 paid hours per month are dedicated to internal workshops. We mentor and receive mentorship, hold regular design critique sessions and enhance our best practices. We create publications, product discoveries, case studies and also speak at webinars and conferences.

• Own and maintain the Quality Management System in compliance with ISO 13485
• Ensure that software and system development processes align with FDA expectations and applicable regulatory frameworks
• Lead QA activities across web, mobile (iOS, Android), backend, and integrations
• Define and maintain test strategies, test plans, and release criteria
• Ensure full traceability between requirements, risks, tests, and releases
• Lead verification and validation activities
  , including documentation, evidence generation, and reporting
• Prepare for, support, and participate in internal, external, and regulatory audits
• Review and approve quality documentation, SOPs, and test reports
• Collaborate with product, engineering, regulatory, and clinical stakeholders to embed quality into product life cycles
• Track quality metrics, defects, and CAPAs, and drive continuous improvement
• Ensure proper handling of deviations, nonconformances, and change control

• 10+ years of experience in Quality Assurance
  , including at least 5 years in regulated environments
• Proven hands‑on experience with ISO 13485 and ISO 14971
• Direct experience supporting FDA submissions (510k, De Novo) and audits
• Strong understanding of software validation and lifecycle documentation
• Experience with risk management and traceability practices
• Experience testing software, mobile applications, and backend systems
• Familiarity with QA and test management tools and processes
• Excellent communication skills and strong attention to detail Nice to have
  • Experience with SaMD (Software as a Medical Device)
  • Experience with MDR submissions
  • Familiarity with audit tools and quality dashboards
  • Experience integrating QA in Agile / Dev Ops workflows
  • Prior experience working with or guiding contractors / external partners
  What we offer
  • International, remote-first team
  • Opportunity to work on complex, high-impact systems
  • Modern engineering culture with autonomy, ownership, and the ability to influence architectural direction
  • Continuous professional growth and learning opportunities
  • A transparent and collaborative company culture
  • Room for continuous professional growth — mentorship, knowledge-sharing, and diverse challenges

  We believe that a supportive and inspiring environment is essential for focusing on what truly matters: solving real user problems and delivering excellent products for our clients. That’s why we operate in a remote-first setup
  , offering a flexible schedule, long‑term stability, and all the tools needed to work effectively.

  Our team is equipped with modern hardware, software, and access to a wide range of high-quality learning resources, supporting continuous growth and productivity. We trust our people to work in the way that suits them best, while staying connected and aligned as a team.

  We’re passionate about creating an environment where people love to work together. Get to know the team and our company culture.