Supplier Quality Management Engineer
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
- Supporting the strategic procurement team in supplier audits
- You act as a link between the operational procurement team and suppliers
- You will act as a subject matter expert for all related supplier quality procedures and ensure compliance with relevant procedures
- Supporting production in case of supplier problems
- Creation of inspection plans for incoming goods
- Supporting 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
- Supporting Quality Engineers in ensuring the regulatory conformity of processes and products within the framework of quality assurance, taking into account the 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
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