Job Summary. POSITION SUMMARY. Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT. Drive a cul...
Job Summary. The Documentation Coordinator is responsible for processing document changes at the site, either via the electronic document management systems or vis paper-based Document Change Notices (DCNs). They also are responsible for binding, issuing, reconciling, and filing logbooks and laboratory notebooks, as well as for compiling documents for Annual Product Report Updates (APR), coordinating SOP implementation and update of SOP binder se...
Job Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs. Responsibilities Represent Regulatory on assigned product/project teams. establish and implement regulatory ...
Job Summary. This position performs primary notification and is a consolidation point for receiving and processing basic complaint investigation activities. The position ensures timely and accurate investigation of customer complaints to help Fresenius Kabi comply with all regulatory obligations while meeting the customers' needs. Responsibilities. Capture all complaint information and ensure all necessary documentation (i.e. sample information, ...
Job Summary. Responsible for initiating, monitoring and executing the lyophilization cycle for all lyophilized products and initiating, monitoring and executing the Terminal Sterilization cycle for all terminally sterilized products. Responsibility includes but not limited to: preparation of the equipment, operating manual and automatic mechanical systems, executing computer driven programs, troubleshooting equipment, unloading product, maintaini...
Job Summary. Act as the primary contact for Warrendale Service Depot, supporting the Medical Device business. Accurate data entry of LVP service orders, initiation of Debt Memo request and APRISO work orders. Responsibilities. Create SAP service orders for the LVP Service Depot, and initiate Debt memos. Identify and report potential complaints per criteria on service orders. Assist in maintaining Depot Daily reporting, and customer follow up. Per...
Job Summary. The Sr Principal Engineer performs sustaining engineering activities and technical project management related to disposables / consumable products for the Ivenix Infusion System portfolio. Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative sol...
Job Summary. The Project Manager is responsible for the effective management (organization, financial/project planning, execution, control and evaluation) of all aspects of assigned projects. The Project Manager will effectively collaborate with project governance boards, communicate project status to management and provide resolution of project issues. This position requires a dynamic individual with a strong engineering background, adept projec...
Job Summary. The Sr. Manager, Manufacturing Quality US Supply Sites will assure that all activities associated with manufacturing of products within the portfolio of all sites manufacturing for distribution in the US comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ). The oversight will also extend to the assurance of coverage of the Laboratory Quality Assurance (LQA) activitie...
Job Summary. The Director for Strategy & Business Development will serve as a contributing member within Transfusion Medicine & Cell Therapies division, focusing on the Fresenius Kabi Cell and Gene Therapy (C>) portfolio. The position reports to the Director of Marketing (Cell & Gene Therapies). The candidate will work closely with R&D, Commercial, and Regulatory to establish, evolve and execute strategic and tactical initiatives for a new prod...
Job Summary. The Principle Electrical Engineer is responsible for product design, product development, and product support of Automated Blood Technology medical devices. Responsibilities. Design and develop new or improved electronic sub-assemblies for medical devices. Design activities include analog and digital circuit design, schematic capture, printed circuit board layout, component selection, tolerance analysis, prototype development, and tr...
Job Summary. The ISO Systems & Sustainability Manager is responsible for the management and maintenance of all local requirements under the ISO 14001 - Environmental Management System (EMS), ISO 45001 - Occupational Health and Safety Management System (OHSMS), and ISO 50001 - Energy Management System (EnMS) for the Plant (Production Unit), in accordance with the current ISO Standards, as well as all Sustainability initiatives. This position drive...
