The University of Zurich (UZH) is a world-leading institution renowned for its excellence in research and education. With a vibrant scientific community and a focus on interdisciplinary collaboration, UZH fosters groundbreaking discoveries in the biomedical field. Our state-of-the-art facilities and commitment to innovation provide the perfect environment for researchers to push the boundaries of knowledge and develop new solutions to global health challenges. The vision is to position Zurich Hub for Drug and Device Development (ZH3D) as a primary center of excellence for drug and device development at the UZH and in Switzerland. Already existing GxP services at the UZH/University Hospital Zurich (USZ) will be bundled and complemented with newly created services. The GxP academy will promote a variety of well-established and new courses at the UZH/USZ and ZH3D will support innovation in the field of drug and device development by providing GxP expertise and quality assurance.

Overall Purpose of the Post

The goal is to establish and manage at the UZH a coordinated and centralized Quality Management System (QMS) according to ISO 13485 with regulatory compliance to In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) as well as meeting Swiss regulatory requirements.

Your Responsibilities

• Ensuring that processes needed for the QMS are established, documented, implemented and maintained,
• maintaining and organizing the organization's internal quality audit program and managing corrective and preventive action plans,
• ensuring compliance with national and international standards and legislation,
• reporting to top management on the effectiveness of the QMS and any need for improvement,
• ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization (UZH/USZ),
• delegating Q personnel to facilities within the organization and external liaison on matters relating to QMS activities
  
  

Your profile

• Requisite expertise in the field of medical devices
• Special expert knowledge required in IVDR and MDR
• At least three years of experience in QMS related to medical devices and specific training in ISO 13485 and ISO 14971
• Awareness of relevant standards and guidelines
• Competencies in all aspects of the QMS, specifically:
• Audit management
• Design and development including verification & validation
• Document release and changes
• Drafting of specifications and process validation
• Improvement: Corrective and preventative actions and root cause investigations
• Manufacturing and product release
• Post market surveillance and vigilance
• Risk management
• Communication with regulatory authorities
• Proven ability to manage a QMS
• Strong interpersonal skills including ability to interact with high degree of diplomacy are required
• Excellent oral & written communications skills in German and English