Experience in contract manufacturing environments8-12+ years of experience in medical device manufacturing
Sobre nuestro cliente
Medical manufacturing company is looking for a Quality Manager responsible for ensuring that all products manufactured at the facility comply with applicable regulatory requirements and quality standards for the markets in which they are distributed.
Descripción
Ensure compliance with applicable regulatory requirements including FDA regulations and other international medical device standards.
Assess regulatory impact of engineering or process changes and ensure proper documentation and compliance.
Drive continuous improvement initiatives focused on reducing quality risks and failure modes.
Collaborate closely with multiple medical device customers to ensure compliance with their regulatory and quality requirements.
Work cross-functionally with Engineering, Operations, Supply Chain,



and Program Management to ensure quality compliance across the manufacturing process.
Lead and participate in Kaizen and continuous improvement initiatives to enhance quality performance and operational efficiency.
Perfil buscado
8-12+ years of experience in medical device manufacturing or regulated industries.
Experience in contract manufacturing environments is highly preferred.
Strong knowledge of FDA regulations and medical device quality standards.
Experience managing or supporting regulatory and customer audits.
Background in manufacturing processes such as plastics, device assembly, extrusion, or machining is highly desirable.
Qué Ofrecemos
Competitive compensation package.
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📌 Quality Manager (Tijuana)
🏢 Michael Page
📍 Tijuana