We are seeking a leader with experience in Quality Management Systems for medical devices to drive compliance, continuous improvement, and process effectiveness in a highly regulated manufacturing environment.
Key Responsibilities: Lead the implementation, maintenance, and improvement of the QMS in accordance with ISO 13485 and applicable regulatory requirements.
Coordinate internal, customer, and external audits, ensuring effective closure of findings.
Oversee CAPA, document control, change control, and management review processes.
Monitor quality metrics and drive actions to strengthen system performance.
Collaborate with Operations, Engineering, and other departments to ensure compliance throughout New Product Introduction (NPI) and production.




Develop the team and promote a culture of quality and compliance.
Qualifications: Bachelor’s degree in Engineering or a related field.
Solid QMS experience within the medical device industry.
Knowledge of ISO 13485, FDA requirements, and risk management.
Experience leading audits, CAPA processes, and quality teams.
Advanced English proficiency to communicate with customers and corporate teams.
Experience in catheter or Class III medical device manufacturing preferred.

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📌 QMS Manager (Centro-Norte)
🏢 Foxconn Baja California
📍 Centro-Norte