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.