Tammy Estrada

Manufacturing Operations Leader with 20+ years of experience in medical device and electronics manufacturing, including 9+ years in leadership roles. Proven track record leading teams of 70+ employees, optimizing production performance, reducing costs, and driving continuous improvement through Lean and Six Sigma methodologies. Strong expertise in S&OP-aligned production planning, material flow, and inventory management, ensuring traceability, GMP/FDA compliance, and optimization of warehouse and supply chain operations.

Senior Manufacturing Supervisor at MEDTRONIC (2021-01 – 2026-01)

• Led teams of 70+ employees across sterile and non-sterile packaging operations, including Team Leaders, Production Control, Expeditors, and Machine Operators.
• Applied Lean Six Sigma Green Belt methodologies to drive continuous improvement and structured problem-solving.
• Executed S&OP-aligned production planning, ensuring schedule adherence, material availability, and efficient workflow management.
• Directed Tier meetings across multiple levels, optimizing KPIs such as Scrap, Yield, OEE, NCMR, Efficiency Hours, Work Hours, Productivity, Schedule Adherence, and Labor Efficiency using Livelink and Power BI.
• Resolved conflicts and coached employees using Listen–Reflect–Respond communication tools to strengthen team performance.
• Promoted a high-performance culture through Tiers, Clusters, OHS, recruitment, evaluations, reclassifications, recognition programs, Standard Work, and cross-functional collaboration.
• Ensured full compliance with quality standards, safety requirements, SOPs, GMP, and FDA regulations.
• Demonstrated strong proficiency in Microsoft Office, Cornerstone, Factory Work, Livelink, Ariba, Kronos, SAP, and Power BI for reporting and operational analysis.
• Served on the Plant Emergency Response Team, supporting emergency preparedness and incident response.
• Implemented the G4 Changeover Project, achieving $350K in savings and earning the Gold Award at the Quest Competition (Sept 2024).

Production Control Supervisor at TERUMO CARDIOVASCULAR DIVISION (2017-01 – 2021-01)

• Achieved a 12% reduction in Device History Record (DHR) lead time, improving documentation flow and production readiness.
• Implemented JD Edwards, MES, and SAP ERP systems, reaching 90% manufacturing efficiency across assigned operations.
• Designed the Angio-Seal process flow and updated MES/SAP procedures to strengthen traceability and compliance.
• Experienced in MES configuration, UAT execution, and supporting MES modeling and system enhancements.
• Resolved SAP production order discrepancies, including material and financial variances, ensuring accurate cost and inventory control.
• Led daily manufacturing meetings, managing headcount, line balancing, and schedule adherence while providing system support to Manufacturing, Cost Accounting, and Supply Chain.
• Annual Circle of Excellence – SHINJIRARENAI Award (Terumo Corporate).
• Recognized for SAP Integration Test Cycle Excellence.
• Achieved $70K reduction in Component Scrap Project.

Production Control Specialist / Supply Chain & Warehouse Operations at TERUMO CARDIOVASCULAR DIVISION (2012-01 – 2017-01)

• Supported scheduling and planning processes to ensure operational alignment across production and supply chain activities.
• Managed JD Edwards system operations and delivered user training, providing cross-functional support to Manufacturing, Cost Accounting, and Supply Chain.
• Monitored and analyzed key metrics (Open Orders, Lead Time, Scrap, Overtime, Yield) to drive schedule adherence and operational efficiency.
• Ensured SAP-driven control of incoming materials, maintaining inventory accuracy, traceability, and GMP compliance.
• Coordinated material flow for on-time production readiness, supported cycle counts, resolved discrepancies, and optimized warehouse and supply chain processes.
• Employee of the Year 2017.

Senior Team Leader at ST. JUDE MEDICAL CV DIVISION (2003-01 – 2012-01)

• Led daily production operations ensuring full compliance with cGMP, ISO, Safety, and SOP requirements.
• Prepared standard production and efficiency reports to support operational visibility and data-driven decision-making.
• Facilitated daily cross-functional meetings to resolve issues, maintain schedule adherence, and support continuous workflow improvement.
• Implemented 5S improvements in two key production areas, strengthening organization, efficiency, and visual control.
• Oversaw non-conformance lot sort activities and training, utilizing SAP/NCMR for documentation and traceability.
• Promoted effective communication and teamwork to enhance operational performance and employee engagement.
• Identified and executed cost-saving and efficiency initiatives by analyzing Scrap, Yield, OEE, and Lead Time KPIs, driving measurable improvements in operational performance.
• Achieved Orange Belt certification.
• Awarded 2nd Top Cost Reduction Project for measurable operational savings.

Quality Control Inspector at ST. JUDE MEDICAL CV DIVISION (2002-01 – 2003-01)

• Supported the transfer and validation of five manufacturing processes, including molding, ensuring readiness, documentation accuracy, and quality compliance.
• Performed software validation and troubleshooting for the Visual Inspection System, improving reliability and inspection accuracy.
• Led and maintained the Non-Conformance Material Report (NCMR) system, ensuring timely documentation, segregation, investigation, and closure of non-conforming materials.
• Served as Quality Data Source Owner for key metrics (Yields, Lot Compliance, Top Offenders, Pareto analysis), enabling data-driven decision-making.
• Conducted internal process audits to ensure compliance with cGMP, procedures, and regulatory requirements, driving corrective and preventive actions.
• Evaluated and implemented quality requirements for incoming materials and contract services, including periodic supplier cGMP audits.

Quality Control Inspector at INTEL, LTD (1993-01 – 2001-01)

• Inspected electrical boards using technical drawings and visual aids to ensure compliance with quality and functional standards.
• Identified non-conforming units and certified acceptable products, supporting reliable output for electronics manufacturing operations.

Bachelor's Degree in Business Administration – Columbia Central University (2003-01)

Advanced Certification in Supervision and Business Leadership – Ana G. Méndez University (UAGM)