Quality Assurance Manager IVDR/MDR

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

What we offer

Our employees benefit from a wide range of attractive offers. More

Location

Zurich Hub for Drug and Device Development

Information on your application

Further information

Questions about the job

Ralph Schiess
sekretariat@dmmd.uzh.ch

Working at UZH

The University of Zurich, Switzerland's largest university, offers a range of attractive positions in various subject areas and professional fields. With around 10,000 employees and currently 12 professional apprenticeship streams the University offers an inspiring working environment on cutting-edge research and top-class education. Put your talent and skills to work with us. Find out more about UZH as an employer!