Perla Ramos

Quality Systems professional with fourteen years of progressive experience in QMS implementation, CAPA management, root cause analysis and regulatory compliance. Strong background in ISO standards, risk-based thinking, documentation control and audit readiness. Demonstrated success in reducing non-conformities, improving audit outcomes and building sustainable quality cultures.

Quality Systems Engineer at ICU Medical (2023-01 – Present)

• Internal audits coordinator.
• Implementation and coordination of process audits.
• Management of customer complaints.
• Coordinator of non-conforming material.
• Product configuration in Agile PLM and Oracle.
• Implementation of engineering changes.
• Management review readiness and presentation to staff.
• Support on product registration and external audits.
• Implementation of problem-solving techniques.
• Management of corrective and preventive actions.

Quality Engineer at ICU Medical (2023-01 – 2023-12)

• Control of quality process on assembly lines.
• Non conformances investigation and root cause analysis.
• Complaints investigations and personnel management.
• Implementation of improvement projects for cost reduction and process efficiency.

Document Control Coordinator at ICU Medical (2015-01 – 2023-12)

• Implementation of Agile PLM system for control of QMS documents and changes.
• Review and implementation of engineering changes.
• Item configuration in Oracle system.
• Support on engineering projects and transfers.
• Training on Agile system, procedures changes and Quality System.
• Main contact between corporate and site for document control purposes.
• Implementation of improvement projects for cost reduction and process efficiency.
• Decision making and problem solving.
• Certified Internal Auditor ISO 9001, ISO 13485.
• English language C1 Advanced.
• Quality tools.
• Problem solving methodologies.
• Root cause analysis.

Quality System Administrator at Noranco (2015-01 – 2015-12)

• Document and record control.
• Leader of internal audits.
• Follow up on corrective actions.
• Management review readiness.
• Training on quality topics.
• Personnel management.

Document Control Auxiliary at ALCO (2014-01 – 2015-12)

• Document and record control.
• Training on QMS requirements.
• Internal and external audits.
• Follow up on corrective actions

Quality Assistant and Document Control at Fluidmaster (2012-01 – 2014-12)

• Elaboration of production and quality reports.
• Document and record control.
• Process audits.
• Training on QMS requirements.
• Internal audits.

Bachelor's Degree in English Teaching – UANL (2008-01 – 2013-12)

Master's in Industrial Engineering – UANL (2024-01)

Master's in Business Administration in Quality and Productivity – IEP (2025-01)