Easter Seals Jobs

Requistion ID : 77087

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.

Team Lead (m/f/d) Quality Management Systems

The Team Lead Quality Management Systems (m/f/d) provides the oversight and integrity for multiple site Quality Management Systems (Bensheim, Zurich, and Berlin), including direct responsibility for the leadership and compliance to applicable regulatoy requirements. Directs the activities of the site QA Systems Managers in Bensheim , Quality Monitoring and Improvement, Document Control/Change Management, CAPA Management, computer system validations (CSV) and Audits. The associate is responsible and accountable to assure that the quality management systems are in substantial compliance with all applicable regulatory requirements, while helping to achieve Group and corporate financial objectives. This opportunity is a permanent and unlimited role at our R&D and manufacturing site in Bensheim.

Your Responsibilities:

• Responsible for development and establishment of Corporate and CTS Group Quality Systems to meet all applicable global regulatory requirements (US FDA, EU MDR, ISO 13485, MDSAP, etc.).

• Facilitates the awareness of regulatory and customer requirements throughout the organization.

• Provides expertise and guidance in interpreting Standards, governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation.

• Collaborates with multiple cross-functional colleagues to ensure achievement of standards and regulations during product development and commercialization activities.

• Develops and manages (directly and indirectly) relationship and interface with the regulatory agencies (domestically and internationally) for the site Bensheim.

• Assist the Director QMS in preparation and conduction of management reviews and KPI control

• Associate is a participating member of the Quality Management Reviews, CAPA Boards, etc.

• Manage the Quality department in a manner that strives to attain site, Group and Corporate quality goals.

• Provides management support to the internal audit teams.

• Responsible for the continuous improvement of the established quality management system (QMS) and departmental processes to achieve Group and Corpporate goals.

Your Profile:

• Bachelor's degree in engineering or other related technical discipline or Master's degree in a related discipline, preferred

• 5 years of related work experience, experience in the medical device industry preferred

• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

• Lead, manage and implement initiatives in support of QA/RA department objectives.

• Present at all levels of the organization to achieve results.

• Build relationships at all levels of the organization to meet tight deadlines and targets.

• Communicating effectively at all levels of an organization. This includes written and verbal communication and presentations.

• Very good written and spoken German and English skills