Head of/Director Quality Management Juarez

Ambu A/S; Ciudad Juárez; Presencial; MXN 1,655,000 - 2,207,000; Jornada completa

Descripción de la vacante

A global medical device company is seeking a Head of Quality Management to oversee quality processes at their Juarez site. The role involves ensuring compliance with FDA and ISO standards while leading a talented team. Candidates should have a Bachelor's degree and substantial experience in the medical device industry. This position offers competitive compensation and a collaborative environment.

Servicios

Competitive compensation

Supportive environment

Opportunities for growth

Formación

• Minimum 10 years of relevant work experience, including 5 years in management and 5 years in the medical device industry.
• Proven experience with FDA, ISO, and other regulatory requirements.
• Strong leadership and communication skills.

Responsabilidades

• Act as Site Quality Management Representative.
• Oversee establishment and maintenance of the Quality Management System.
• Lead the final release of products and manage quality risks.

Conocimientos

Leadership

Communication

Conflict resolution

Educación

Bachelor's degree in a relevant field

Descripción del empleo

Head of Quality Management – Juarez

Location: Juarez, Mexico

Department: Global 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.

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?

Apply now to join Ambu as our new Head of Quality Management in Juarez!