Requirements: English
Company: WhatJobs
Region: Zrich , Zurich
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
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!