In the position of Quality Manager, you will be entrusted with overseeing and directing quality management processes across two key manufacturing sites. Your primary mission is to ensure that all products consistently meet stringent quality benchmarks, while driving continuous enhancement initiatives. With your deep expertise in quality systems and production optimization, you will lead efforts to streamline processes and sustain high-quality standards across operations. Collaborating closely with cross-functional teams—such as engineering, research, and development—you will act as the main contact point between internal departments, external suppliers, and partner facilities within the business. Primary Responsibilities: Team Leadership & Development: Lead, mentor, and manage quality teams across two production facilities, cultivating a high-performance culture centered on continuous improvement. Supervise the work of quality personnel, ensuring alignment with organizational goals. Quality Management & Compliance: Ensure that products are produced in compliance with both regulatory guidelines and company-specific quality requirements. Offer expert guidance in regulatory adherence, production process control, risk evaluation, and quality management systems. Oversee the regulatory submission process and ensure all required documentation is prepared accurately. Lead initiatives aimed at optimizing quality and operational efficiency by implementing process improvements. Conduct root cause investigations and oversee Corrective and Preventive Action (CAPA) processes. Manage resources for developing and validating test methods, analyzing statistical data, and executing process validations and component qualifications. Interdepartmental Collaboration & Reporting: Collaborate with R&D, production teams, and supply chain functions to align quality operations with overall business objectives. Report quality metrics and strategic initiatives to senior leadership, offering insights for continuous quality improvement. Engage with suppliers and manage supplier relationships to ensure quality standards are met. Maintain robust reporting systems to facilitate management reviews and CAPA evaluations. Required Expertise & Qualifications: Bachelor's degree in Engineering, Quality Management, or an equivalent field. In-depth understanding of ISO 13485 standards and FDA regulatory requirements. Strong proficiency in team leadership, technical writing, problem-solving, and communication. Demonstrated experience in conducting internal and external audits. At least 7 years of experience in a quality management role within industries such as medical devices, automotive, or related fields. Advanced skills in software tools (MS Office, databases, statistical analysis tools). Fluency in both English and German languages. Flexibility to travel internationally as needed.