Quality Compliance and Risk Manager
Date: Jun 13, 2025
Location: Zurich, CH, 8047
Company: Dentsply Sirona, Inc
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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history 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 dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.
Working at Dentsply Sirona you are able to:
Develop faster - with our commitment to the best professional development.
Perform better - as part of a high-performance, empowering culture.
Shape an industry - with a market leader that continues to drive innovation.
Make a difference -by helping improve oral health worldwide. |
Quality Compliance and Risk Manager
We are looking for an experienced and talented Quality Compliance and Risk Manager to join our team in Zurich. You will play a crucial role within our organization with focus to maintain 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:
- Responsible for planning and executing the risk management process according to ISO 14971 - identify, assess, and manage risks associated with medical and non-medical devices throughout their lifecycle in close collaboration with R&D, QM, Clinical, UX, Cybersecurity, Marketing, and other cross functional teams;
- Prepares and maintains the risk management documentation; supports HHE
- Subject Matter Expert for the RM process during external and internal audits
- Responsible for the QMS process risk management (process owner)
- Responsible for the process non-conformities (process owner)
- Support to the quality lead on-site regarding other quality related processes, e.g. internal audits, supplier audits, external audits, CAPA management, training and others
- Other Quality related tasks – leads or supports specific quality projects,
- Carries out internal audits as a Lead auditor or in an audit team
- Monitor regulations and standards updates related to risk and quality and implement necessary process changes
- Lead investigations into significant quality events and ensure effective risk-based CAPA and change control
- Additional responsibilities as assigned
What you'll bring:
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 risk management of medical devices, preferably SaMD; experience in quality management or regulatory affairs of medical devices, preferably in a SW environment
Key Skills, Knowledge & Capabilities:
- Profound knowledge of MDR, CFR FDA, MDSAP, ISO 14971, ISO 13485, IEC 62304
- Good technical understanding of software as a medical device and non-medical software products
- Lead Auditor Qualification
- Skilled in using QMS and risk management software/tools (e.g., FMEA, risk matrices, document control platforms)
- Able to lead cross-functional projects and facilitate risk-based decision making
- Excellent communication and team player skills
- Independent and results-oriented way of working
- Fluency in English (written and spoken) – German is a plus
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