Responsible for leading the Quality Assurance organization to ensure compliance with applicable regulatory requirements, quality standards, and customer expectations. This role provides strategic and operational leadership for the Quality Management System (QMS), oversees product quality throughout the manufacturing lifecycle, and drives a culture of quality, compliance, and continuous improvement.

Key Responsibilities
Quality Management System
- Ensure the effectiveness and continual improvement of the Quality Management System (QMS).
- Maintain compliance with FDA, ISO 13485, MDR (where applicable), and customer requirements.
- Lead internal and external audits and regulatory inspections.
- Monitor quality metrics and drive improvements through data analysis.

Product Quality Assurance
- Oversee incoming, in-process, final inspection, and product release activities.
- Ensure effective management of nonconforming products, investigations, deviations, and CAPAs.
- Review and approve quality documentation, including procedures, validation documentation, and engineering changes.





Operations Support
- Partner with Manufacturing and Engineering to improve process capability and product quality.
- Support New Product Introduction (NPI), process validations (IQ/OQ/PQ), and manufacturing transfers.
- Ensure effective implementation of risk-based quality controls.

Regulatory & Customer Compliance
- Act as primary quality representative during customer audits and regulatory inspections.
- Support customer complaint investigations and field actions when required.
- Ensure compliance with Quality Agreements and customer-specific quality requirements.
- Support supplier qualification, monitoring, and supplier corrective actions.
- Collaborate with Supplier Quality on material-related investigations and risk assessments.

Leadership & Talent Development
- Lead, coach, and develop Quality Engineers, Supervisors, Inspectors, and Technicians.
- Establish performance objectives an

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