Leida Rondón

Quality Asssurance Manager

Quality Manager @ DAS Medical

• Ensure that the organization’s Quality Management System conforms to customer, internal, ISO 13485, and regulatory/legal requirements.
• Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
• Manage the monitoring, measurement, and review of internal processes.
• Lead a team of Quality engineers, inspectors, auditors, analysts, and technicians.
• Report to top management on the performance of the QMS (results of quality audits, corrective actions), including the need for improvement.
• Conduct periodic management review.
• Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.
• Keep up on standards, regulations/laws, issues, and news with respect to product quality.

Supplier Quality Engineer @ Getinge Group

• Implement the Quality Management System according to ISO 13485, FDA 21 Part 820 and our Corporate guidelines.
• Internal auditor.
• Responsible for making sure purchased products meet the company’s needs and expectations.
• Perform audit and validation to the suppliers.