J. MANUEL BUSTAMANTE G.

QA dynamic leader, team player & results oriented, with a strong strategic vision and ability to mentor and supervise QA teams, looking for a challenging position as Quality Manager. Manufacturing professional with robust experience in process optimization and quality control. Skilled in Lean manufacturing, Six Sigma methodologies, and CAD software. Strong collaborator, adaptable to changing environments, and consistently driving for operational excellence and team success. Known for problem-solving abilities and effective communication.

• ISO13485 / QSR – Medtronic
• Hoshin Kanri - Medtronic
• Personnel Mgt. – Medt., NSK
• QSIT/Quality Tools – Medt.
• ISO9002 / EN46002 - MDM
• Kaizen / 5S’s – Medt, NSK
• Lean Mfg – Medtronic
• CAPA’s/FMEA’s – NSK
• Quality Costs - EMSA
• 6σ (Greenbelt) - Medtronic
• Process Val/Qual – Medt, MDM
• SPC / QIS - EMSA

• Ensured compliance with Regulatory and Corporate requirements resulting in Zero Major Observations from Initial & Surveillance FDA / TUV Audits.
• Achieved 50% cycle time reduction of Change Orders processing – Lean Project.
• Improved quality of Vascular High Runners End Products thru systematic defects reduction from 95,000 to 18,000 DPM’s.
• Completed successful Guide Catheter Process / Products Transfer from Danvers to Tijuana facility, exceeding a 10% the Yield goal.
• Achieved 30% reduction of Custom Packs Complaints - 6σ Project.

• Dependable
• Self-Motivated
• Ambitious
• Time Flexibility
• Willing to Travel