Responsibilities

- Manage and ensure compliance with the Quality Management System under applicable standards such as ISO 9001, ISO 13485, and customer-specific requirements.
- Ensure compliance with regulations applicable to medical and electronic products.
- Lead internal, external, customer, and regulatory audits.
- Develop and implement continuous improvement strategies focused on reducing defects, rework, and cost of poor quality.
- Supervise Incoming Quality, IQC, IPQC, OQC, SQE, Document Control, and Supplier Quality areas.
- Monitor and track quality key performance indicators (KPIs).
- Coordinate root cause analysis and corrective/preventive actions using tools such as 8D, CAPA, Fishbone, 5 Why’s, and FMEA.
- Ensure proper validation and control of electronic manufacturing and special processes.
- Participate in New Product Introduction (NPI) transfers and engineering changes.
- Ensure training and development of quality department personnel.
- Maintain effective communication with customers regarding quality issues, complaints, and corrective actions.




- Coordinate certification programs and regulatory compliance activities.
- Promote a culture of quality, safety, and continuous improvement within the organization.

Education & Experience

- Postgraduate degree preferred.
- Minimum of 5 years of experience in similar roles.
- Advanced English proficiency (C2 level).
- Experience supervising supervisors and leading teams.
- Direct customer interaction experience.

Technical Skills

- ISO 9001
- ISO 13485
- IPC-A-610
- FDA / GMP (preferred)
- Core Tools: PFMEA, Control Plan, SPC, MSA
- Lean Manufacturing and Six Sigma
- CAPA and Root Cause Analysis
- SMT processes and electronic assembly manufacturing
- Interpretation of technical specifications and documentation

Soft Skills

- Leadership
- Effective communication
- Decision-making
- Problem-solving
- Negotiation with customers and suppliers
- Organization and follow-up
- Ability to work under pressure

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📌 Quality Manager | Electronics - SMT | CT (Tijuana)
🏢 Grupo TECMA
📍 Tijuana