RESPONSIBILITIES:
Supplier Quality Engineer is accountable for the supplier quality life cycle management with the following duties:
61 Ensure defined quality levels for purchased materials, OEM-in products, and service providers, incl. qualification, development, integration, monitoring, and auditing suppliers
61 Input for the creation and maintenance of inspection plans for incoming goods inspections, incorporating expertise from operational areas, and ensure that development specifications and development agreements with suppliers are adequately addressed in the process
61 Ensure supplier quality readiness in an early stage within the development process
61 Support product design and development process with respect to specification, risk management, validation, and control of supplier-related aspects
61 Input for selection, evaluation, and qualification of material/product and service providers to ensure stable operation processes
61 Drive continuous improvement through utilization of quality methods
61 Ensure and further develop compliance of the related technology division regarding ISO 9001, 13485, (US FDA 21 CFR Part 820 and or GMP as applicable)
61 Define, implement, and disseminate the quality technical tools, processes, and systems to support the appropriate execution of the QM system
61 Responsibility for claim management towards dedicated suppliers and support for non interruption of production due to supplier material

Tasks :
61 Define and monitor deployment of engineering and material specifications including material risk failure assessment in close collaboration with R&D and the supplier
61 Coordination of specific material components regarding "Material Compliance" in the interpretation of the legal requirement and compliance by the supplier.
61 Advanced Quality Planning for critical materials identified by value analysis in corporation with procurement and R&D
61 Negotiate and ensure quality assurance agreements with suppliers
61 Assist with the supplier selection process including evaluation and development in close collaboration with the procurement department
61 Support supplier relocation activities (location/ supplier change)
61 Conduct supplier audits to qualify and assess suppliers' quality and manufacturing capabilities to support the supplier qualification process, surveillance program, and supplier development
program
61 Develop, execute and analyze supplier quality KPIs to report on quality issues, trends and losses
61 Provide input for creation and maintenance of inspection plans and instructions for incoming goods inspection, ensure technical feasibility, and thus advise and assist operative production in managing inspection plans and instructions.
61 Drive supplier actions to verify part and process quality to reduce the need for incoming inspection activities
61 Initiate and review supplier complaints that are relevant on the global/TC level (describe problems, steer internal containments, drive supplier for containments, conduct root cause analysis and corrective actions)
61 Coach functional owners and process owners as needed

Qualification:
61 Bachelor or higher degree in engineering or quality management education background with strong technical understanding in specific disciplines;
61 At least 5 years of work experience in a high-tech manufacturing environment for quality management, technical positions, or procurement-related positions and min. 2 years of experience in supplier quality management;
61 Strong hands-on experience in Supplier Quality Management, incl. PPAP, APQP, supplier qualification and continuous improvement, complaint handling and problem-solving, supplier quality performance monitoring, etc.
61 Good knowledge and experience in NPI, localization, and project management
61 Profound knowledge in ISO9001, ISO 13485, and cGMP; good understanding of US FDA 21 CFR Part 820 and/or IVDR/MDR is a PLUS.
61 Proficient in English, both written and spoken, is essential.
61 Good MS Office and reporting/Power BI capabilities, experience in Infor and SAP/ARIBA is a plus
61 Profound knowledge and experience in communications, negotiation, data-driven analysis, and problem-solving
61 Exposure to multicultural working environment
61 Willingness to travel over 40% of the work time

Main Competence:
Customer Focus:Building strong customer relationships and delivering customer-centric solutions
Decision Quality: Making good timely decisions that keep the organization moving forward
Collaborates:Building partnerships and working collaboratively with others to meet shared objectives
Drives Results:Consistently achieving results, even under tough circumstances