Senior Quality Manager

B. Braun Avitum Saxonia GmbH is seeking a Senior Quality Manager for its Quality department in Dresden to handle complex quality and compliance matters, lead quality projects and develop its quality management system.

• Act as a technical expert and strategic contact for complex quality and compliance matters
• Lead complex quality projects, including legally valid documentation relating to product quality and risks
• Provide technical leadership to Quality Support staff
• Initiate and support measures to improve product quality and the process capability of manufacturing operations
• Provide clear information and support sound decisions on product quality matters, including advice to management
• Continuously improve quality assurance processes and develop the quality management system
• Train departments in product quality, methods and processes, and continuously raise awareness of product quality
• Lead audits and regulatory inspections at the site

• Completed degree in engineering, natural sciences or medical technology
• Strong technical understanding and analytical thinking
• Several years of experience in the medical device industry, ideally in an international environment
• Thorough knowledge of DIN EN ISO 13485 and the regulatory requirements of 21 CFR Part 820
• Business-fluent spoken and written English
• Strong communication and persuasion skills and confidence in handling challenging situations
• High flexibility and an independent, structured approach focused on solutions
• Organisational skills, commitment and a high level of personal responsibility
• Team player with strong skills in working across departments and the ability to build trusting cooperation