• Collaborated with R&D and Manufacturing Engineering during product design and development to create pilotmanufacturing process for Class III medical device for clinical study use.• Performed device final calibration, device acceptance, test methods and approved DHRs for 2 production runs (1 for design verification, 1 for clinical study).• Conducted a manufacturing gap assessment per ISO 13485 and CFR Part 820 standards to identify areas of improvement needed in the newly set-up manufacturing environment.• Executed internal audits to rectify errors and identified 10+ nonconformances and opportunities for improvement.• Assisted in qualifying 5 new suppliers for ASL by supporting supplier audits to assess supplier QMS compliance.• Used quality tools such as CAPA, NCMR and SCAR to ensure product quality.• Improved product quality yields by updating incoming & in-process inspection with revised AQL and Critical to Quality (CTQ) plans based on ISO 2859.• Conducted safety audits and led hazard investigations to ensure safety in R&D & production work environments.• Provided back-room support for ISO 13485 audit.

• Accelerated review and approval of over 50+ SOPs, WIs, and CAD drawings.• Conducted investigation on out of tolerance/calibration equipment to trace and analyze the root cause for riskassessment, reducing equipment downtime.• Proposed asset management via RFID & barcode systems to overcome discrepancies in IMTE traceability.• Supervised the inspection defect management module with defect review, testing of components, andinstrumentation, achieving reduction in defective products.

• Developed manufacturing techniques and lean tools such as Value Stream, and 5S to increase efficiency.• Implemented preventive maintenance to reduce machine downtime.• Communicated with suppliers and customers to forge B2B/B2C relationships, increasing customer satisfaction.

Lead the sales and marketing of products during the Covid-19 pandemic.

Lead a team of 25 students to train the applicants and manage the Placement drives.