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.
