Quality Assurance Manager
vor 4 Wochen
Your Role
- Ensure the quality of purchased materials from suppliers by providing expert advice on quality aspects.
- Implement best practices for managing supplier non-conformities and incoming inspection processes to guarantee regulatory compliance.
- Develop and monitor key performance indicators (KPIs) to measure supplier performance, incoming inspection effectiveness, and complaint management.
- Foster strong partnerships with suppliers to drive quality improvements and adherence to medical device industry standards and regulations.
- Collaborate with cross-functional teams to drive quality initiatives and resolve supplier-related issues.
- Drive continuous improvement efforts to enhance quality, reduce defects, and optimize costs within the medical device supply chain.
- Stay up-to-date with evolving medical device industry trends and regulations pertaining to supplier quality and inspection.
- Drive digitalization and process improvement initiatives to enhance supplier quality assurance.
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 ability to manage multiple priorities simultaneously.
- Excellent interpersonal and leadership skills, ability to effectively manage internal/external cross-functional teams.
- Analytical mindset with 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.
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