Quality Assurance Lead – ISO-13485, CAPA, Lean

Medline; Mexicali; On-site; MXN 420,000 - 680,000; Full time

Job summary

Medline in Mexicali seeks a qualified Quality Lead to coordinate CAPA for customer complaints and drive continuous improvement across processes. The role emphasizes PFMEA reviews, supplier and internal collaboration, and adherence to GMPs, ISO 13485 standards, and regulatory requirements.

The ideal candidate has 3–5 years in Quality Control/Engineering, a solid background in medical devices, and strong leadership and communication skills, with fluency in English.

Qualifications

• Bachelor degree in Administration, Engineering, Manufacture, Industrial or related
• 3-5 years of Quality Control/Engineering experience
• Medical Devices Experience
• ISO 13485 Lead Internal Auditor certification
• English proficiency 90%
• Lean manufacturing, Six Sigma BB/GB
• Minitab
• SPC
• Strong leadership
• Effective communication
• Self-driven
• Management skills / Decision Making

Responsibilities

• Lead and coordinate CAPA for Customer complaints and process non-conformities.
• Communicate product quality issues, data analysis, trends, and information to internal customers.
• Continual process reviews through PFMEA documents.
• Develop processes and plans to identify trends and focus on customer complaints, and in-process non-conformances.
• Develop and define measurement equipment to evaluate and perform component inspection
• Define effective control plans for warehouse to operations delivery of raw materials’ processes.
• Lead continuous improvement projects focused on quality improvement, and cost reductions.
• Perform periodic audits of the accuracy and cleanliness of component storage locations and communicate results with appropriate warehouse personnel.
• Support the implementation and improvements for Good Manufacturing Practices (GMPs).
• Comunicaciones
• Practice effective communications with peers, internal customers, suppliers and management on progress of activities.
• Maintain effective communication with Corporate counterparts.
• Relación con los empleados
• Collaborate with peers and internal customers to improve quality, processes, and documentation.
• Seguridad y Salud
• Abide to all safety and security Medline policies.
• Sistemas de Calidad
• Serve as an ISO-13485 Lead Internal Auditor, participating in the Internal Audit Program.
• Ensure compliance with domestic and international regulations associated with product lines and processes

Skills

Leadership

Communication

Decision making

Self-driven

Education

Bachelor degree in Administration, Engineering, Manufacture, Industrial or related

Tools

Minitab

SPC

Excel

Microsoft Office

PowerPoint

Job description

Medline in Mexicali seeks a qualified Quality Lead to coordinate CAPA for customer complaints and drive continuous improvement across processes. The role emphasizes PFMEA reviews, supplier and internal collaboration, and adherence to GMPs, ISO 13485 standards, and regulatory requirements.

The ideal candidate has 3–5 years in Quality Control/Engineering, a solid background in medical devices, and strong leadership and communication skills, with fluency in English.