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Quality & Product Regulations Engineer (m/f/d)
Böblingen
Aktualität: 19.12.2024

Anzeigeninhalt:

19.12.2024, Advantest Europe GmbH
Böblingen
Quality & Product Regulations Engineer (m/f/d)
Aufgaben:
As QA-Product Regulations Engineer (m/f/d) for the SoC Business Group (SoC-BG), you will work within the organization of Quality & Regulatory Compliance. You are responsible for the cross-functional collaboration with and consulting for all affected organizations and suppliers to ensure that our products are safe and meet all applicable legal requirements, Advantest internal requirements, and customer expectations. Accompanying NPIs and manufacturing transfer activities Managing third party competent bodies (CSA, TÜV) for compliance assessments and certification Involvement in CPE activities Influence the design of products and processes to ensure safe products that meet legal requirements and customer expectations. (incl. safety and risk assessments) Interpret Regulatory Compliance Requirements and integrate them into our Product Life Cycle Process. Develop and implement Product Market Access Plans, including product regulations and environmental test plans. (e.g. product compliance and robustness testing) Participate in Product Regulations and Compliance Industry activities that benefit Advantest and our customers. (e.g. ZVEI, IEEE, SEMI) You will also support the SoC Quality Management system (ISO 9001/14001) and develop it further. This includes: Execution of internal audits, facilitation of external audits and maintain the QMS handbook. Deploy quality and problem solving methods throughout various SoC Business Group functions (R&D teams in various locations, Product Engineering and supply chain partners). Enhancement of QA methodology skills within engineering teams will be achieved by trainings and facilitation of FMEA's during new design projects. Support quality issue resolution throughout the supply chain and lead projects with customers, by collaboration with external partners, applying the right QA methodology and defining appropriate KPI's.
Qualifikationen:
Bachelor / Master degree in Electrical, Mechanical or Mechatronic Engineering, Business Engineering (Wirtschaftsingenieurwesen) with strong technical experience Deep knowledge of product safety and EMC standards (e.g. IEC 61010-1, IEC 60204, IEC 61326) and European Directives (Low Voltage, EMC, Machinery Safety) Experience in product testing and compliance certifications ISO 9001 / 14001 experience, knowledge about ISO/TS/IATF 16949; Qualification / experience as internal auditor is highly preferred Proven track record of developing compliance solutions enabling and securing business objectives Outstanding product compliance and good business acumen Analytical skills to drive corrective actions based on KPI's QA methods (e.g. 3x5 Why, FMEA, 8D, Six Sigma, statistical analysis ...) Strong background in electrical and/or mechanical engineering required Fluent written and verbal communication skills in German and English language Good Communication skills and Team Player Demonstrated interpersonal and teamwork skills as well strong ownership Project management and presentation skills Highly independent and pro-active with a result-oriented attitude and strong sense of accountability

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