• Review and Finalized 16 Site Transfer Quality Plans by verifying task applicability, engaging with stakeholders, collecting evidence of completion, documenting test reports, and ensuring closure.• Provide expertise and support during internal and external site audits to ensure compliance.• Develop and executed validation protocols (IQ, OQ, PQ) for cleanrooms, laboratories, and CNC areas at different sites.• Revise of Design Verification Tests Protocols to validate product compliance• Developed and finalized validation protocols and test reports• Equipment Assessment for LCM• Led the coordination of deviation within validation processes to address compliance gaps• Prepared audit observation reports to document findings and recommend corrective actions• Validation of relabeling process of product ensuring regulatory standards.• Collaborated with cross-functional teams, including Regulatory affairs, R&D, Operations, Technical Services, to align project objectives

• Production line transfer from Miami to Juarez, ensuring integration of manufacturing line into new facilities.• Performed equipment validations, including IQ, OQ, PQ, and characterization.• Executed product validation processes, leveraging DFMEA, design validation, and requirements traceability matrices (RTM).• Created and managed Engineering Change Orders (ECOs) within the Adaptiv PLM system.• Oversaw tooling modifications to optimize production efficiency and product quality.• Revised and updated process work instructions to reflect operational changes and improvements.• Conducted root cause analyses to reduce scrap and improve yield on production lines.

• Executed equipment validations including IQ, OQ, PQ, CSV, and TMV to ensure compliance and efficiency.• Identified initiatives for project improvements and implemented them successfully.• Provided technical support for Non-Conformance Reports (NCRs) using ETQ systems.• Oversaw packaging equipment operations, maintenance, and validation to maintain quality standards.

• Led continuous improvement projects to optimize processes and productivity, resulting in increased efficiency.• Managed non-conformances to maintain high product quality standards.• Provided technical support during line startup to minimize production delays.• Utilized statistical analysis to monitor processes and identify areas for improvement.

• Led initiatives to enhance production line performance, increasing throughput and minimizing downtime to meet production goals.• Developed strategies to reduce scrap generation, resulting in significant cost savings and improved product quality.• Implemented cycle time reduction strategies, improving production speed and operational efficiency.

• Provided engineering support for Change Orders (ECOs) and conducted tooling analysis for new projects at Stoneridge North America.• Utilized cost analysis to identify cost-saving opportunities and optimize resource allocation, improving project profitability.• Expertise in harness crimping process and maintained accurate databases for materials, components, and inventory tracking.