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

vor 4 Wochen

Oberkochen, Deutschland ZEISS Gruppe Vollzeit

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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