This person will be managing a team of Quality professionals in the encompasses areas related to the QMS, specifically Doc Control, Training, CAPA and Internal /External Audits. The role is responsible for the development and maintenance of the document management systems/processes in terms of applicable regulations and industry practices. This position will be responsible for managing and driving continuous improvements within the QMS while ensuring alignment with Corporate and other DMSI sites. In addition, the position will focus on the coordination of compliant systems as well as the assurance of overall compliance activities and initiatives within DMSI.
Establish and maintain an electronic document management system compliant with regulatory, and quality requirements. Provide Document Control support including but not limited to processing, publishing, and distributing controlled documents. Ensure timely release of documentation for production process and associated activities.
Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
Collaborate with cross-functional departments to ensure timely implementation of DCRs. Establish and maintain records management system including secure storage, retrieval, retention and destruction.
Maintain and improve the existing training program. Ensure the training program is meeting all aspects of Adult Learning. Work with all departments supporting production and operations to establish departmental training modules.
Responsible for the lifecycle (hiring, developing, retaining) of direct reports. Coach and guide individual contributor staff. Manages performance of the team.
Lead the CAPA program by developing and implementing the strategy, systems and tools to ensure a robust corrective and preventive actions (CAPA), tracking of CAPA completion, and assessment of effectiveness.
Develop and provide input in the development of Audit schedules.
Supports audits (internal, external, third party) in order to verify that regulatory and quality requirements have been met.
Contribute in the continuing development of the Quality culture at Draeger.
Support new hires by introducing Draeger’s Quality Management System as part of New Employee Orientation.
Interact with all departments to develop and implement functional documents as part of Quality Plans.
Manage the coordination of Quality metrics within DMSI and roll-up to Corporate.
Monitor timelines related to QMS records for targets, due dates and completion activities.
Lead and oversee development of a Quality Newsletter for DMSI communications.
Performs other duties as needed and assigned.