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Head of/Director Quality Management Juarez
hace 8 horas
Head of Quality Management – Juarez Location: Juarez, MexicoDepartment: Global Quality ManagementReports to: VP, Global Quality ManagementCompany: Ambu Ambu is seeking a dynamic and experienced Head of Quality Management for our Juarez site. Join us to drive excellence, ensure compliance, and lead a talented team in a global, innovative environment. Key Responsibilities Act as Site Quality Management Representative and designated Management Representative. Oversee and ensure the effective establishment, implementation, and maintenance of the Quality Management System (QMS) in accordance with FDA, ISO, and other applicable standards. Lead the final release of Ambu A/S and King System products, with authority to stop manufacturing, shipments, and deliveries if quality is at risk. Initiate recalls, CAPAs (Corrective and Preventive Actions), and NCRs (Nonconformance Reports) as needed. Approve or reject change requests, validation/verification activities, and product/lot releases. Coordinate and facilitate Management Review meetings and all external/corporate audits. Lead the document control process, risk management system, and internal/supplier audit programs. Ensure all employees are trained in cGMP and familiar with the quality policy. Manage departmental budget, talent development, and cross-functional teamwork. Oversee activities related to Micro and Sterilization departments, training, and health/cleanliness policies. Serve as the primary contact for regulatory authorities and ensure compliance with evolving standards. Ensure the proper operation, control, and compliance of cleanroom (controlled environment) areas, including monitoring of environmental conditions, gowning procedures, and personnel behavior to maintain product sterility and compliance with regulatory standards. Qualifications Bachelor’s degree in a relevant field. Minimum 10 years of relevant work experience, including at least 5 years in management and 5 years in the medical device industry. Proven experience with FDA, ISO, and other regulatory requirements. Strong leadership, communication, and conflict resolution skills. Fluent in English (reading, writing, and speaking). What We Offer A key leadership role in a global organization committed to quality and innovation. The opportunity to shape quality culture and processes at a critical manufacturing site. Competitive compensation and benefits. A collaborative, supportive, and growth-oriented environment. Ready to make a difference in healthcare quality? Apply now to join Ambu as our new Head of Quality Management in Juarez About Ambu Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific. For more information, please visit ambu.com or follow us on LinkedIn. #J-18808-Ljbffr
