Xsensio seeks a Senior Quality Engineer in Vaud, CH, to manage QMS and regulatory documentation for Class IIa/IIb devices throughout the full development lifecycle.
This position supports a growing team at a critical phase of device development. The engineer works within a fast-paced, multidisciplinary environment, overseeing the entire product lifecycle from design history file creation and risk management to supporting Swissmedic submissions.
Responsibilities
- Manage the daily operations of the quality management system.
- Collaborate with engineers and scientists to draft Design History File and Device Master Record documents.
- Ensure test reports, deviations, and batch records are captured consistently and traceably.
- Oversee the complete CAPA process, from initial identification to final closure.
- Maintain supplier qualification records and purchasing documentation.
- Own and update the risk management file in accordance with ISO 14971 across various device workstreams.
- Coordinate outsourced ISO 10993 biocompatibility evaluations.
- Provide quality documentation support for clinical investigation packages.
Requirements
- At least five years of experience in quality roles within the MedTech sector.
- Proven track record working with Class IIa or IIb medical devices.
- Strong foundational knowledge of ISO 13485 standards.
- Practical understanding of ISO 14971 and ISO 14155.
- Comprehensive grasp of MDR requirements, including Technical File structure and notified body expectations.
- Experience handling ethics committee or Swissmedic submission requirements from a quality documentation standpoint.
Nice to have
- Prior experience as the primary owner of a quality management system.
- Direct experience creating DHF documentation for technically novel or complex devices.
About the company
Xsensio is an innovation-driven digital health company dedicated to solving the lack of real-time, continuous monitoring of relevant health parameters. The company aims to revolutionize healthcare with simple, minimally invasive solutions, realizing its mission through the Lab-on-Skin™ wearable platform.
- Innovation-driven digital health focus.
- Dedicated to solving the lack of real-time, continuous monitoring of relevant health parameters.
- Mission is realized through the Lab-on-Skin™ wearable platform.
- Aims to revolutionize healthcare with simple, minimally invasive solutions.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.