Quality Compliance and PMS Manager

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Date: Jun 13, 2025

Location: Zurich, CH, 8047

Company: Dentsply Sirona, Inc

 

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 Post-Market Surveillance Manager

 

We are looking for an experienced and talented Quality Compliance and Post-Market Surveillance (PMS) Manager to join our team. 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'll do:

 

  • Develop and maintain PMS processes and documentation in compliance with applicable standards and regulations, EU MDR, MDSAP and others.
  • Author and update PMS Plans, PMS Reports, PSURs, and PMCF summaries, as applicable.
  • Coordinate with cross-functional teams to gather real-world data, trend results, and field performance feedback.
  • Collaborate with Risk Management and Design Quality teams to ensure that PMS data informs ongoing product risk and usability evaluations.
  • Subject Matter Expert for the PMS process during external and internal audits
  • Responsible for the Training process (process owner)
  • Responsible for the Documentation Control, including control of external documents, primarily industry standards, regulations and guidance documents (process owner)
  • 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 PMS and implement necessary process changes
  • Additional responsibilities as assigned
  • Acts as Deputy PRRC for PMS

 

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 13485,  ISO 14971, IEC 62304
  • Good technical understanding of software as a medical device and non-medical software products
  • Lead Auditor Qualification
  • 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%