**City**:Juárez, Chihuahua, Mexico- **State**:
- **Country**:Mexico- **Business Area**:Quality Assurance- **Department**:Global Quality Management- **Employment Type**:Full-time- **Req ID**:****-
- **Head of Quality Management - Juarez**- ** Location**: Juarez, Mexico
**Department**: General Quality Management
**Reports to**: VP, Global Quality Management
**Company**: Ambu-
- **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.
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- **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.
**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?
**About Ambu
Ambu has been bringing the solutions of the future to life since ****.
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.

📌 Head Of/Director Quality Management Juarez (Ciudad Juárez)
🏢 Ambu
📍 Ciudad Juárez