Edgar Jacuinde

- Developed and maintained quality standards for cardiovascular bioprosthesis production (Medical Devices Class III and II).

- Led root cause analysis and implemented CAPA for quality issues.

- Supervised and mentored a team of inspectors, enhancing operational efficiency.

- Direct responsibilities in the manufacturing process end-to-end, from Receiving Raw Materials at warehouse, Manufacturing inside a Cleanroom ISO class 6, Packaging and Lebling, Final Release of Sterile product, and Shipping.

- Developed validation protocols for cardiovascular bioprosthesis and neurovascular products.

- Inventory management using SAP.

- Led non-conforming material investigations along corrective actions.

- Collaborated with cross-functional teams to ensure quality standards.

- Provided support as Subject Matter Expert for Keizen events related to Service Excellence, Finance, Cost Reduction, Inspection Optimization, Organizational Health, New Product Development to name a few.

- Provided primary input for hiring, promotion, performance, and rewards for direct labor.

- Led a manufacturing organization of a headcount over 180, delivering medical devices as finished products and sub-assemblies Class III and II.

- Managed manufacturing areas inside multiple cleanrooms ISO class 6 and 7.

- Led the compliance of safety regulations, cost saving improvements, and inventory management.

- Delegated tasks to multiple employees while maintaining efficient workplace.

- Created build schedules cascaded end-to-end aligned with multiple sister manufacturing sites and global supply plans.

- Led a team in executing equipment maintenance and process improvements in cleanrooms ISO class 7.

- ESD standards Subject Matter Expert for manufacturing electronic devices.

- Performed root cause analysis following DMAIC methodology.

- Owned a workshop dedicated to process improvements.