Design Quality Manager (m/w/d)

Design Quality Manager DQM (M/W/D)

Dentsply Sirona is the world's largest provider of dental products and technologies and supports dentists and dental technicians in offering better, faster, and safer care in all dental fields. We are proud to be a preferred partner for dental practices, clinics, dental laboratories, and authorized distributors worldwide. The headquarters of Dentsply Sirona is located in Charlotte, North Carolina. As dentistry advances, our global team will continue to drive the incredible development in dental medicine and modern patient care on a global scale. Our stocks are listed on the US technology stock exchange NASDAQ under the symbol XRAY.

We are looking for an experienced and talented Design Quality Manager DQM (M/W/D) to strengthen our team.

Your Responsibilities:

• Oversight and technical accompaniment of validation and verification activities within product development according to design control guidelines
• Ensuring compliance and continuous improvement of design control and quality management processes
• Development, implementation, and establishment of quality strategies, standards, and best practices in the design and development environment
• Planning, conducting, and evaluating design reviews, failure analyses, and quality-related development decisions
• Responsibility for risk management according to ISO 14971 for defined product groups, including creation, maintenance, and monitoring of risk management records
• Technical support of usability and cybersecurity teams regarding risk-relevant issues
• Active participation and monitoring of FMEA activities in collaboration with R&D and supply chain
• Driving initiatives for continuous improvement to enhance the robustness, safety, and reliability of product designs
• Supporting EU conformity assessment (legacy products) and participating in the creation and maintenance of technical documentation according to MDR and other applicable EU regulations
• Close cooperation with regulatory affairs, especially in the context of change controls and information transfers
• Interdisciplinary collaboration with development, process engineering, approval, and other interfaces for sustainable quality and compliance assurance
• Fulfillment of tasks according to the QMS role matrix, including possible deputy functions
• Participation in quality-related projects and support in the preparation, conduct, and follow-up of internal and external QMS audits at the Bensheim site

Your Qualifications:

• Successfully completed higher education with a technical background (mechanical engineering, electrical engineering, business engineering, quality management) or equivalent
• First-hand experience in quality management in a company with a certified quality management system, ideally from a MDR/IVDR environment
• Solid knowledge of medical device regulations such as FDA Q System Regulation, MDR, and applicable industry standards like ISO/ANSI 13485, ISO 14971, IEC 62304, and others, particularly with regard to design control guidelines
• Experience in dealing with international approval requirements (e.g., FDA 510k, letter to file, etc.)
• Ability to effectively work within the organization through influence and relationships
• Excellent communication skills in English (C1); German (C1)
• Proficient use of common IT systems/tools (SAP, MS Office, Smartsolve)
• Very good communication and analytical skills
• Knowledge of relevant quality management tools and methods

As part of our team, you will experience the spirit of an international and innovative leader in the dental industry. In addition to an attractive compensation package, you will be entitled to a variety of social benefits, such as 30 days of annual leave, flexible working hours with the possibility of mobile work, and an excellent pension plan. Our subsidized canteen, employee parking spaces, and company sports offers are available to you. Furthermore, you will receive comprehensive training, access to LinkedIn Learning, and the opportunity for personal and professional development through our global mentoring and coaching program. Take advantage of the chance to develop yourself personally and professionally. Benefit from the advantages of the JobRad and design your commute in an environmentally friendly and health-promoting way. We also offer free charging options for e-cars and e-bikes. Our employees are important to us: we offer a comprehensive, global employee support program that provides many benefits.