Head of/Director Quality Management Juarez

hace 3 días

Barrio Juárez Chihuahua, México Ambu AS A tiempo completo

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

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