Quality Assurance Manager IVDR/MDR 80-100%
Universität Zürich
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Zurich Hub for Drug and Device Development
Quality Assurance Manager IVDR/MDR 80 - 100 %
Start of employment 01.07.2025
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
What we offer
Our employees benefit from a wide range of attractive offers. More
What we offer
Work-Life Balance
- Flexible working models (such as part-time positions, mobile working, job-sharing)
- Childcare at the kihz foundation of UZH and ETH
More Learning and Development
- Wide range of continuing education courses of UZH and the Canton of Zurich
- Language Center run jointly with ETH Zurich
More Food
- Food and drinks at reduced prices in the UZH cafeterias
- Lunch-Check-card with UZH contribution
More Healthcare
- Special conditions on the Academic Sports Association ASVZ
- Free seasonal flu vaccinations
- Rest and relaxation at the quiet room in the university tower
More Discounts
- Private traffic: Carsharing, rent a vehicle, parking space
- Digitalization: Hardware, software, mobile phone subscriptions
- Special conditions on hotel reservations
More Conditions of Employment
- Policies of the UZH
- Most UZH staff are employed according to public law
More International Services
- Support for people from outside Switzerland
More Campuses
- Campuses Zurich City, Zurich Irchel, Oerlikon and Schlieren
- Sites Zurich West, Old Botanical Garden, Botanical Garden and Lengg
More
Location
Zurich Hub for Drug and Device Development
Further information
Questions about the job
Ralph Schiess Contact Form
Contact question to: Ralph Schiess
Your Name *Your Mail Address *Your question *I accept the privacy policySend Thank you for your message. We will get
back to you shortly. 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!
More → https://www.uzh.ch/cmsssl/en/explore/work.html
Please apply via our job portal www.jobs.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! More
Quality Assurance Manager IVDR/MDR 80 - 100 %
Start of employment 01.07.2025
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
What we offer
Our employees benefit from a wide range of attractive offers. More
What we offer
Work-Life Balance
- Flexible working models (such as part-time positions, mobile working, job-sharing)
- Childcare at the kihz foundation of UZH and ETH
More Learning and Development
- Wide range of continuing education courses of UZH and the Canton of Zurich
- Language Center run jointly with ETH Zurich
More Food
- Food and drinks at reduced prices in the UZH cafeterias
- Lunch-Check-card with UZH contribution
More Healthcare
- Special conditions on the Academic Sports Association ASVZ
- Free seasonal flu vaccinations
- Rest and relaxation at the quiet room in the university tower
More Discounts
- Private traffic: Carsharing, rent a vehicle, parking space
- Digitalization: Hardware, software, mobile phone subscriptions
- Special conditions on hotel reservations
More Conditions of Employment
- Policies of the UZH
- Most UZH staff are employed according to public law
More International Services
- Support for people from outside Switzerland
More Campuses
- Campuses Zurich City, Zurich Irchel, Oerlikon and Schlieren
- Sites Zurich West, Old Botanical Garden, Botanical Garden and Lengg
More
Location
Zurich Hub for Drug and Device Development
Further information
Questions about the job
Ralph Schiess Contact Form
Contact question to: Ralph Schiess
Your Name *Your Mail Address *Your question *I accept the privacy policySend Thank you for your message. We will get
back to you shortly. 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!
More → https://www.uzh.ch/cmsssl/en/explore/work.html
Please apply via our job portal www.jobs.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! More