Medical Device QMS Leader | ISO 13485 & Compliance

Foxconn Baja California; Tijuana; Vor Ort; MXN 800.000 - 1.050.000; Vollzeit

Zusammenfassung

Foxconn Baja California seeks a leader to manage Quality Management Systems for medical devices in a highly regulated manufacturing environment, driving compliance, continuous improvement, and process effectiveness. Responsibilities include leading ISO 13485 and FDA-aligned QMS, audits, CAPA, document and change control, and management review, plus cross‑functional collaboration across NPI and production.

Requirements: engineering degree, strong QMS experience in medical devices, knowledge of

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QMS leadership

Regulatory compliance

Process improvement

Cross-functional collaboration

English communication

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

Audit management

CAPA system

Risk management

Jobbeschreibung

Foxconn Baja California seeks a leader to manage Quality Management Systems for medical devices in a highly regulated manufacturing environment, driving compliance, continuous improvement, and process effectiveness. Responsibilities include leading ISO 13485 and FDA-aligned QMS, audits, CAPA, document and change control, and management review, plus cross‑functional collaboration across NPI and production.

Requirements: engineering degree, strong QMS experience in medical devices, knowledge of