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

Ihr ZEISS Recruiting Team:

Marina Löw