Your Role
1. responsible to advise all quality aspects regarding Supplier Quality Assurance to ensure safety, effectiveness, reliability, and quality capability of purchased material from suppliers
2. implement best practices for managing supplier non-conformities and incoming inspection processes while ensuring precise assessment of incoming materials and components meet regulatory standards
3. define and monitor key performance indicators (KPIs) to measure supplier performance, incoming inspection effectiveness, and complaint management with a strong focus on regulatory compliance
4. establish and maintain strong partnerships with suppliers, fostering quality improvements and adherence to the medical device industry standards and regulations
5. collaborate closely with cross-functional teams, including quality management, production, procurement, and engineering, to drive quality initiatives and sustainably resolve supplier-related issues
6. drive continuous improvement efforts aimed at enhancing quality, reducing defects, and optimizing costs within the medical device supply chain
7. stay well-informed about evolving medical device industry trends and regulations pertaining to supplier quality and inspection
8. drive digitalization and process improvement initiatives to enhance supplier quality assurance to its next level
9. maintain constant contact with the global Supplier Quality teams to achieve continuous development
Your Profile
10. Bachelor or Master of Science/ Engineering or comparable, required
11. minimum 5 years of experience in supplier quality management or related roles in quality
12. 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
13. expert in interpretation of technical drawing (GD&T) and AQL sampling plan table
14. strong problem-solving skills and the ability to manage multiple priorities simultaneously
15. excellent interpersonal and leadership skills, ability to effectively manage internal/external cross-functional teams with the understanding of cross-functional tensions
16. analytical mindset with the ability to identify trends and implement data-driven decisions
17. willingness to travel domestically and internationally as required
18. fluent in German and English, French would be an advantage
Your ZEISS Recruiting Team:
Marina Löw