Product Quality Engineer in Niedergebra

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 / DeutschBackgroundExternal 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 M.Sc- or B.Sc. 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 & ResponsibilitiesTransfer product speci?cation into test equipment requirements (URS)De?ne and develop test equipmentDe?ne acceptance criteria for test equipmentAccountable for creation of test planImplementation of test planning at supplier and RDIDe?ne sample size for in-process control (IPC), product release testing and incoming goods inspectionConduct internal and supplier trainings regarding product quality inspectionAccountable for test equipment quali?cation, test method validation, including correlation studies to RDI test equipmentTechnical Q&V documentation review at supplier regarding test equipment quali?cation, test method validationResponsible for review of ?rst article inspection (FAI) incl. veri?cation of the tolerance situationTechnical assessment of changes of test equipment and test planningMust HavesM.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise3+ years of relevant work experience in a GMP regulated, producing companyExperience in IVD product manufacturing and testingKnowledge of Process Management methodologies (Lean, Six Sigma, etc.)Experienced in test equipment quali?cation and test method validationIn-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.Ability to think strategically and systemically, willingness to try new ideas and participate in changesSelf-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solutionAbility to effectively communicate with all levels of the organization by establishing credibility and building rapportPerforming well under pressure and decisivenessExcellent communication skills in German and EnglishTravel required up to 10%Reference Nr.: Rolle: Product Quality EngineerIndustry: PharmaLocation: RotkreuzPensum: 80 - 100%Start: )Duration: 12 + MonthsDeadline: 07/09/2026About usITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. #J-18808-Ljbffr