Design Quality Assurance Product Center Manager - Ta-180

Design Quality Assurance Product Center Manager Quality Business Partner to product Value Streams to ensure complaint products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived. Tasks performed regularly which form the essential characteristics of the position. Design Control - Works as part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients as well as regulatory and corporate SOP compliance. - Reviews and approves design control deliverables along the product development process as well as design changes - Reviews and approves Technical Reviews, Design Reviews and Phase Exit Reviews - Reviews and approves Design and Technology Transfer Deliverables - Guides engineering teams through the product development and design change process in a compliant and efficient way - Creates quality plans and deviation notices if deemed necessary - Provides training on Design & Development relevant quality requirements - Review and Approval of Detailed Impact Assessments for Level 2 Design Changes. In addition, responsible of the definition, monitoring and closure of Risk Management activities. Product Conformity - Main contact for medical device PD-Accessories marked with the CE-mark. - Meeting the essential requirements for the CE declaration of conformity - Checking CE conformity annually - Ensuring technical file complete and up-to-date - Submitting the declaration of conformity - Initiating, supporting and releasing design changes (product safety change) - Providing support during creation and maintenance of the clinical evaluation - Responsible for the List of Standards Post Market Surveillance - Manage Post Market Surveillance activities - Analyze PMS data collected and initiate the required activities. - Detect and report trends NC/CAPA - Acts as a Quality Approver for design control related topics - Acts as a Quality Assignee for system related topics Monitoring and Continuous Improvement - Defines and tracks quality KPIs for continuous improvements and provides quality performance and trending to Vertical - Drives continuous improvement in the area of quality processes, tools and methods in close alignment with the central SysQaRa unit - Prepares and conducts regular quality review meetings - Provides input to Management Reviews - Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position Representation of Risk Manager - Risk management throughout the complete product life cycle - Creating risk assessments with the support of the Risk Management Responsible - Assessing potential product risks (from market observation and quality problems) Audit - Facilitates internal and external audits for Home - Acts as an auditee for relevant chapters Requirements : Required training and education Bachelor or master degree in engineering or a similar technical field required, such as medical technology or a technical apprenticeship with further training to be a technician, along with relevant professional experience. Required professional experience 2 - 5 years' related experience Required technical knowledge - Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, IEC 60601 and ISO 14971. - Knowledge with Biocompatibility-Testing of Medical Devices according to ISO 10993 - Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding - Must possess an intimate understanding of Design Controls and solid engineering expertise enabling them to guide the development of new products and design changes - Experience with development of design input and traceability through verification and validation V&V; activities - Experience with identification of relevant compliance standards and associate testing - Demonstrated presentation and communication skills - Strong oral and written communication skills - Ability to communicate technical information to non-technical audiences - Familiar with agile methodology Languages English level B2 IT skills - Proficient with Microsoft Office applications. - Proficient with ALM systems - Proficient with PDM systems - Proficient with QMS software #J-18808-Ljbffr