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. Visitwww.dentsplysirona.comfor 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 toaccommodationrequest@dentsplysirona.com.
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.