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Design Quality & Risk Manager

Dentsply Sirona -
Zürich, ZH

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Details zur Stelle

Leistungen

Unterkunft

Qualifikationen

Englisch
Master
Bachelor
Risikomanagement
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

Date: Jun 18, 2026

Location: Zurich, CH, 8047

Company: Dentsply Sirona, Inc

Requistion ID: 83680

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.

Dentsply Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

Design Quality and Risk Manager

We are looking for an experienced and talented Design Quality and Risk Manager to join our team. You will play a crucial role within our organization with focus on maintaining specific areas of the Quality Management System compliant to internal policies, applicable standards and external regulatory requirements. You will lead the design, implementation, and maintenance of a robust risk management framework across the entire product lifecycle, ensuring compliance with applicable global regulations and standards. The successful candidate will also support broader quality compliance initiatives, including audit readiness and continuous improvement.

What you will do:

Assure high quality of new product development in close collaboration with R&D
Assure high quality of the product documentation
Assure data accuracy and data integrity Support product registrations
Coordinate Non-conformance process and the associated activities CAPA Management Process and Product Change Management and Documentation Controls Internal and Supplier Audits; support during external audits
Collaboration with cross-functional teams Project Management Support to the quality lead on-site regarding other quality related processes
Collaborate with Risk Management and Post Market Surveillance teams to ensure consistent documentation.
Responsible for the Internal Audit Program
Responsible for the Documentation Control, including control of external documents, primarily industry standards, regulations and guidance documents
Support to the quality lead on-site regarding other quality related processes, e.g. external, internal and supplier audits, CAPA management, and others
Monitor regulations and standards related to Design Control and implement necessary process changes
Additional responsibilities as assigned

Who you are:

Education: Bachelor or Master in engineering, computer science, life science or other related fields. SW background is a plus

Years and Type of Experience:

Minimum of 5 years professional experience in design and risk management of medical devices, specifically SaMD
Experience in quality management or regulatory affairs of medical devices in a SW environment

Key Skills, Knowledge & Capabilities:

Profound knowledge of MDR, CFR FDA, MDSAP, ISO 13485, ISO 14971, IEC 62304
Good technical understanding of software as a medical device and non-medical software products
Able to lead cross-functional projects
Excellent communication and team player skills
Independent and results-oriented way of working
Fluency in English (written and spoken) – German is a plus
Travel activities: 10%

Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility: All successful applicants must be eligible to work in the country the position is based.

Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected].

Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.

Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.

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