Senior Manager Quality Systems
Business Unit: Information Technology
Requisition Number: 230492
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 35%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
Siemens Healthineers is currently looking for an experienced and talented Senior Manager of Quality. The Senior Manager will be responsible for the development and implementation of Medical Device Quality systems. He/she will report directly to the VP of QA/RA/EHS for Siemens Molecular Imaging and be responsible for sites in IL and TN.
The primary job responsibility of the role is to develop and sustain a robust quality management system to ensure compliance to 21 CFR Parts 820, 803, 806, and 1000, ISO 13485, EU Medical Device Regulations(MDR), MDSAP, and other applicable standards and regulations. In addition, the role will be responsible for developing and maintaining the Document Control and Training program for the business.
· Managing the Internal Audit program, CAPA program, Documentation and Training program
· Manage team consisting of Quality Engineers & specialists
· Manage external audits including interfacing with regulatory agencies such as FDA, ANVISA, TUV, and BSI.
· Stay informed of new and upcoming regulations and industry trends and drive continuous improvements to the Quality System
· Interface with senior management of the business to drive quality improvements
· Develop training and competence management processes that demonstrate compliance to regulations
· Manage the front room and backroom processes
· Must be familiar with all elements of a Medical Device Quality Management System
· Must be knowledgeable in FDA’s QSRs, ISO requirements, MDD/MDR, and MDSAP requirements.
· Must have experience with Front room and back room management
· Must have experience in Document control & training related processes in a regulated environment
· Engineering/Technical Degree strongly preferred
· 10+ years of direct industry experience
Travel Required: 25-35%