Senior Quality Engineer

About Us

Xsensio is an innovation-driven digital health company dedicated to solving one of the biggest challenges in healthcare: the lack of real-time, continuous monitoring of relevanxt health parameters. Our mission is realized through our breakthrough Lab-on-Skin™ wearable platform—a modular, miniaturized sensing solution offering unique health insights through the continuous and real-time analysis of proteins and hormones at the surface of the skin. We aim to revolutionize healthcare with simple, minimally invasive solutions to improve the standard of care during critical health events.

Job Description

We are seeking an experienced and rigorous Senior Quality Engineer to join our growing team at a pivotal stage of device development. You will own our quality management system and drive quality documentation across design controls, preclinical activities, and clinical investigation — working closely with engineers and scientists throughout the process. This critical role spans the full development lifecycle, from DHF documentation and risk management through to Swissmedic submission support. As part of Xsensio, you will work in a fast-paced, multidisciplinary environment where your contributions will directly shape the path forwardregulatory and quality foundation of a novel wearable biosensing device.

Responsibilities

• eQMS: own and maintain the quality management system day-to-day, ensuring it remains accurate, used, and coherent as the project evolves.
• Design controls: co-draft DHF/DMR documentation alongside engineers and scientists across mechanical and sensing chip workstreams, embedded within technical teams.
• Preclinical documentation: capture test reports, deviations, and batch records in a traceable, consistent way.
• Nonconformances: manage CAPAs from identification through closure.
• Suppliers: qualify and maintain supplier records and purchasing documentation.
• Risk management: own and maintain the risk file (ISO 14971) across device workstreams; identify and resolve gaps before they become problems.
• Biocompatibility: coordinate and maintain ISO 10993 evaluations (outsourced) in alignment with engineers and external consultants.
• Clinical investigation: support quality documentation for the clinical investigation package (CIP, SSED, adverse event records) in line with ISO 14155 and Swissmedic requirements.

Experience

• Background: 5+ years in MedTech quality roles, with direct experience on Class IIa or IIb devices.
• QMS ownership: ideally served previously as primary owner of a QMS, not just a contributor.
• Design controls: hands-on DHF documentation experience, ideally on a technically novel or complex device.
• Preclinical: practical familiarity with test reports, deviations, batch records, and supplier qualification.
• Standards: strong ISO 13485 foundations; working knowledge of ISO 14971 and ISO 14155; solid understanding of MDR requirements including Technical File structure and notified body expectations - not just basic awareness.
• Clinical context: hands-on experience with ethics committee or Swissmedic submission requirements from a quality documentation perspective.