1 of 1 ISO 9001 Jobs in Basingstoke

is a hands-on role for someone who is passionate about building quality into products, not just maintaining documentation. The ideal candidate will have experience with Quality Management Systems (ISO 13485/ISO 9001), Medical Device Software (SaMD), or Regulatory Compliance in a digital health or wellness environment. However, we are also open to hearing from candidates … healthcare, wellness, medtech, or a digital product company. Proven experience liaising with teams on challenging compliance areas Practical experience with one or more of the following: Quality Management Systems (ISO 13485/ISO 9001) Medical Device compliance (MDR, UKCA, FDA 21 CFR Part 820) Software lifecycle & validation (IEC 62304) Understanding of risk management (ISO 14971) and … improve Physitrack's QMS and compliance frameworks. Lead internal quality and risk processes for product development. Collaborate with product teams to ensure features and releases align with MDR and ISO requirements. Manage external consultants working on medical device classification and certification. Partner with Information Security and Legal to align documentation and audit readiness. Prepare the organisation for MDR/ More ❯