- Continuously analyzed and improved production processes to increase efficiency, reduce costs, and enhance product quality by reducing defects on final products and optimizing manufacturing systems and ensuring a safe and healthy work environment.- Worked closely with Quality Assurance to develop and maintained Standard Operating Procedures (SOP) for new processes, ensuring consistency and compliance with regulatory requirements. Trained and mentored production staff on new manufacturing techniques and process improvements.- Developed and maintained process validation protocols in compliance with FDA 21 CFR Part 820 and ISO 13485. Validated old/new equipment (IQ/OQ/PQ) to be in compliance. Managed, inspected, tested and modified the instrumentation, equipment, and procedures, ensuring products met all requirements.- Collaborated with quality and regulatory teams to identify, assess, and mitigate risks associated with manufacturing processes and products, ensuring safety and efficacy.- Lead corrective and preventive actions (CAPA) in response to product and quality issues, ensuring that process improvements were implemented and regulatory requirements were met.- Collaborated with research and development (R&D) teams during the design phase to ensure manufacturability of the device. Provided input on design for manufacturability (DFM) to ensure that the design can be efficiently and safely produced at scale.

Ergonomics improvement project- 15% reduction of musculoskeletal disorder (MSD) by implementing engineering and operational controls- Implementation of weight and lifting limits on material handlers according to OSHA- Implementation of weight activated tables, lifting devices, and trainings for packaging area

- Responsible of coordinating visits to Hospitals- Responsible of acquiring food to distribute on nursing homes- Responsible of communicating and planning activities for the organization- Responsible of leadership and organize annual event, 40 members.- Responsible of leading weekly meetings to track progress inside the organization- Responsible of manage budgets of $35,000 USD (Sponsorship from International Companies and Localbusinesses).