Open to opportunities

Naza Rojas

@nazarojas

Message

I lead compliant medical-device process development, validation, and operational improvement initiatives.

Netherlands

Message

What I'm looking for

I'm looking to lead cross-functional medical-device projects involving process development, validation, quality systems, supplier management, and data-driven continuous improvement.

At Xeltis BV, I lead validation and process-improvement projects that support robust, compliant manufacturing. I bring Production, Quality, R&D, and suppliers together to resolve issues and turn complex technical data into clear leadership insights.

Previously at Boston Scientific, I led end-to-end process development for new products, including laser and chemical processes. I managed CAPEX for equipment and facility expansions, vendor negotiations, FAT/SAT, software qualification, FMEAs, and digital validation workflows.

My earlier work at Microvention Terumo covered supplier quality, SCARs, CAPAs, MES and PLM implementation, Lean Six Sigma improvements, Kardex automation, and JDE integration. I focus on practical, data-driven improvements that strengthen quality, compliance, material flow, and operational performance.

Experience

Work history, roles, and key accomplishments

Current

Senior Process Engineer

Current

Xeltis BV

May 2025 - Present (1 year 3 months)

Leading validation and process improvement projects to ensure robust, compliant manufacturing processes. Driving cross-functional collaboration and applying advanced statistical tools to optimize processes.

Validation Process Improvement SPC Gage R&R CAPA Risk Assessment Cross Functional Collaboration

Process Development Engineer

Boston Scientific

Nov 2021 - May 2025 (3 years 6 months)

Led end-to-end process development projects for new products, including laser and chemical processes. Managed CAPEX for new equipment and facilities, and coordinated cross-functional teams to ensure manufacturability.

Process Development vendor negotiation FAT SAT Risk Assessment ISO 9001 ISO 13485 Data Analysis

Supplier & Quality Project Coordination

Microvention Terumo

Feb 2020 - Oct 2021 (1 year 8 months)

Managed supplier relationships, audits, and reevaluations to ensure compliance with ISO 13485. Led SCAR and CAPA processes from root cause analysis through verification of effectiveness.

Supplier Management Audit ISO 13485 SCAR CAPA Root Cause Analysis

Business Excellence Engineer

Microvention Terumo

Jul 2016 - Feb 2020 (3 years 7 months)

Led MES and PLM implementation support, defining requirements and ensuring accurate BOM integration. Designed and executed Lean Six Sigma projects to reduce waste and optimize warehouse operations.

MES PLM BOM Lean Six Sigma Process Improvement Kardex