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 #J-18808-Ljbffr
Quality Manager | Electronics - Smt | Ct
GRUPO TECMA
tijuana, tijuana
Publicado hace 7 días
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