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.

📌 QMS Manager (Tijuana)
🏢 Foxconn Baja California
📍 Tijuana