Quality Manager

• Provide professional and disciplinary leadership to the Quality Management (QM) team.
  
• Foster a culture of top performance through motivation and development, emphasizing fairness, honesty, and trust.
  
• Demonstrate the ability to adopt different perspectives, understand diverse interests, and encourage collaborative problem-solving.
  
• Proactively take responsibility for activities and effectively delegate, instruct, and support team members in addressing challenges.
  

• Oversee the development, optimization, and systematic application of management systems, including EN ISO 13485, 21 CFR Part 820, and EN ISO 14971, ensuring compliance with all regulatory requirements.
  
• Take the initiative in planning and implementing concepts and procedures for process and quality improvement, coordinating structured change management.
  
• Strategically plan and execute the validation and qualification of production facilities, including re-qualifications.
  
• Supervise the introduction of new processes, ensuring comprehensive documentation in the quality management system.
  
• Develop CAPA (Corrective and Preventive Action) systems to address internal and external complaints, initiating appropriate measures.
  
• Coordinate customer complaints, supporting error analyses, process optimizations, and initiating corrective measures, including product releases and manufacturability assessments.
  
• Plan, implement, and meticulously follow up on internal and external audits.
  
• Prepare and review quality agreements and supplier declarations in collaboration with suppliers and customers.
  
• Create, initiate, process, and monitor corrective measures, organizing the quality area in alignment with market and customer requirements.
  

Requirements

• Bachelors degree in a relevant field; advanced degree preferred.
  
• Extensive experience in quality management, including leadership roles.
  
• Strong understanding and application of relevant standards and regulations (EN ISO 13485, 21 CFR Part 820, EN ISO 14971).
  
• Proven ability to lead and motivate teams, with excellent communication and conflict resolution skills.
  
• Experience in developing and optimizing management systems and implementing change management processes.
  
• Solid knowledge of validation and qualification processes for production facilities.
  
• Familiarity with CAPA systems and handling customer complaints.
  
• Proficiency in planning and conducting internal and external audits.
  
• Excellent organizational skills and attention to detail.
  
• Strong analytical and problem-solving capabilities.