Quality assurance specialist Jobs in Königsbronn

Your Role

responsible to advise all quality aspects regarding Supplier Quality Assurance to ensure safety, effectiveness, reliability, and quality capability of purchased material from suppliers

implement best practices for managing supplier non-conformities and incoming inspection processes while ensuring precise assessment of incoming materials and components meet regulatory standards

define and monitor key performance indicators (KPIs) to measure supplier performance, incoming inspection effectiveness, and complaint management with a strong focus on regulatory compliance

establish and maintain strong partnerships with suppliers, fostering quality improvements and adherence to the medical device industry standards and regulations

collaborate closely with cross-functional teams, including quality management, production, procurement, and engineering, to drive quality initiatives and sustainably resolve supplier-related issues

drive continuous improvement efforts aimed at enhancing quality, reducing defects, and optimizing costs within the medical device supply chain

stay well-informed about evolving medical device industry trends and regulations pertaining to supplier quality and inspection

drive digitalization and process improvement initiatives to enhance supplier quality assurance to its next level

maintain constant contact with the global Supplier Quality teams to achieve continuous development

Your Profile

Bachelor or Master of Science / Engineering or comparable, required

minimum 5 years of experience in supplier quality management or related roles in quality

extensive knowledge of quality assurance & quality management systems, ISO 13485, ISO 9001, AQL, APQP, MSA, 8D, CAPA, MDR, FDA regulations, and other relevant medical device industry standards

expert in interpretation of technical drawing (GD&T) and AQL sampling plan table

strong problem-solving skills and the ability to manage multiple priorities simultaneously

excellent interpersonal and leadership skills, ability to effectively manage internal / external cross-functional teams with the understanding of cross-functional tensions

analytical mindset with the ability to identify trends and implement data-driven decisions

willingness to travel domestically and internationally as required

fluent in German and English, French would be an advantage

Your ZEISS Recruiting Team :

Marina Löw