Senior Quality Engineer

Senior Quality Engineer – Wearable Medical Devices Medical Devices | Wearables | Digital Health | Connected Devices Are you passionate about developing technology that directly improves patient outcomes? I am currently supporting an innovative medical device organisation looking for a Senior Quality Engineer with experience in the wearables, connected health, or digital medical device space. This is an exciting opportunity to join a company developing next-generation healthcare technologies, combining hardware, software, sensors and data-driven solutions to deliver safer and more effective patient care. The Role You will play a key role in ensuring the quality and compliance of complex wearable medical devices throughout the product lifecycle — from design and development through to manufacturing and commercialisation. You will work closely with R&D, Regulatory Affairs, Manufacturing and Supplier teams to ensure products meet the highest standards for safety, performance and reliability. Key Responsibilities ✔ Support quality activities throughout medical device product development ✔ Manage design controls, risk management and verification/validation activities ✔ Support hardware and software integration activities within wearable devices ✔ Drive CAPA, deviations, change controls and continuous improvement initiatives ✔ Collaborate with cross-functional engineering and regulatory teams ✔ Ensure compliance with ISO 13485, FDA 21 CFR 820 and applicable medical device regulations Ideal Background ✔ Medical device quality engineering ✔ Wearable devices, digital health, patient monitoring or connected healthcare technologies ✔ Hardware/software integrated products ✔ Risk management (ISO 14971) and design assurance ✔ Product development environments (NPI, verification & validation) ✔ Working within regulated environments Experience with technologies such as: Wearable sensorsRemote patient monitoring devicesBiosensorsSmart medical devicesMobile health applicationsConnected healthcare platforms