Supplier Quality Management Engineer

Social network you want to login/join with: Supplier Quality Management Engineer Client: EPM Scientific Location: – Job Reference: 5f2194b51b43 Job Views: 8 Posted: 21.01.2025 Expiry Date: 07.03.2025 Job Description: Responsibilities: Assist the strategic sourcing team in reviewing, negotiating and reformulating existing quality agreements with suppliers. Support in the creation of new quality agreements with new or existing suppliers. Support the strategic procurement team in supplier audits. Act as a link between the operational procurement team and suppliers. Serve as a subject matter expert for all related supplier quality procedures and ensure compliance with relevant procedures. Support production in case of supplier problems. Create inspection plans for incoming goods. Support Quality Engineers in reviewing and approving the test strategy, test plans, and test reports in the implementation of product and process changes and their verifications. Assist Quality Engineers in ensuring the regulatory conformity of processes and products within the framework of quality assurance, considering quality methods according to ISO 13485 and 21 CFR Parts 11 and 820. Requirements: Scientific or technical studies (e.g., mechanical engineering, electrical engineering, materials science, physics, process engineering, etc.). Experience in the field of quality assurance and compliance with regulations and quality standards of the medical device industry (21 CFR Part 11 and 820, Regulation (EU) 2017/745, ISO 13485, ISO 14971, ISO 9001). Structured way of thinking ideally combined with QM techniques such as Ishikawa, 5 why, error tree, etc. Experience in the field of risk management, ideally in medical technology. Confident appearance and enjoyment in moderating discussions. Fluent in German and English or willingness to learn them independently. Basic knowledge of the use of Jira & Confluence is an advantage. #J-18808-Ljbffr