- Experience in contract manufacturing environments
- 8-12+ 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