Descripción
--- base: / meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 title: Product Quality Engineer --- Product Quality Engineer ======================== **Product Quality Engineer:** **IVD product manufacturing / GMP / Q\&V documentation / ISO 13485, IVDR, FDA 21 CFR part 820 / ISO 13485, IVDR, FDA 21 CFR part 820 / English / Deutsch** **Background:** External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement. As a Product Quality Engineer you are responsible for the planning and state of the art measurement of the technical test speci?cations. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Engineer provides the necessary training of test procedures to chapter members and stakeholders outside of the organization. The Perfect Candidate has a \- or . degree in Engineering, Natural Science or related disciplines or apprenticeship with a high degree of subject matter expertise and at least 3 years of relevant work experience in a GMP regulated, producing company **.** **Tasks \& Responsibilities:** * Transfer product speci?cation into test equipment requirements (URS) * De?ne and develop test equipment * De?ne acceptance criteria for test equipment * Accountable for creation of test plan * Implementation of test planning at supplier and RDI * De?ne sample size for in\-process control (IPC), product release testing and incoming goods inspection * Conduct internal and supplier trainings regarding product quality inspection * Accountable for test equipment quali?cation, test method validation, including correlation studies to RDI test equipment * Technical Q\&V documentation review at supplier rega