15 ago
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Ambu A/S
|
Chihuahua
15 ago
Ambu A/S
Chihuahua
Department: Global Quality Management
Reports to: VP, General Quality Management
Company: Are you passionate about quality leadership in the medical device industry?
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.
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.
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.
Ensuring 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.
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.
Fluent in English (reading, writing, and speaking).
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.
Ready to make a difference in healthcare quality?
Apply now to join Ambu as our new Head of Quality Manage
📌 Head of Quality Management Juarez (Chihuahua)
🏢 Ambu A/S
📍 Chihuahua