Manager - Supplier Quality Assurance Devices (f/m/x)
vor 1 Monat
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-
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