Edwin Sanchez Email & Phone Number

Carlsbad, California, United States

San Diego, California

Greater San Diego Area

San Diego, California

• Investigated and resolved customer complaint cases regarding medical instruments and in-vitro medical devices in accordance with FDA 21 CFR Part 820 and ISO 13485.
• Effected Root Cause Failure Analysis Investigations of medical instruments, immunoassays, and lateral flow diagnostic devices.
• Tested retained medical devices of several product lines with donor whole blood and serum control materials.
• Recorded investigation data using Good Documentation Practices (GDP).
• Conducted Failure Investigations for issues exceeding historic complaint levels by analyzing several months of data, customer complaints, and previous investigations.
• Assisted with Risk Assessment for identified product issues and elevated failure trends.

Greater San Diego Area

• Fortune 500 company performing high volume/capacity biotech manufacturing. Worked with high-throughput team responsible for producing 500K reagent units per year. Played a key role in packaging and operations by.
• Performed semi-automated bottling of various fluorescent dye-conjugated monoclonal antibodies.
• Executed standardized operating procedures (SOPs) for bottling, capping, and packaging processes.
• Maintained batch record documentation and implemented ISO 9001:2008 management system.
• Performed high volume kit-assembly line operations for ELISA and FITC Fluorescence Microscopy kits.
• Improved standardized activities and processes by development and implementation of Kaizen.

San Diego, CA

• Transnational refrigeration panel systems manufacturing company servicing the United States and Mexico.
• Led insulating panel manufacturing team.
• Supervised insulating panel manufacturing processes (QA/QC).
• Oversaw cooling systems assembly line operations
• Led exothermic polyurethane insulation filling process.
• Assisted with sheet metal cutting and pressing processes.

• Semiconductor Manufacturing company part of Fortune 500 list. Worked with multi-disciplinary R&D team performing materials characterization, failure analysis, and sub-micrometer semiconductor electron imaging.
• Performed failure analysis and quality assurance procedures for semiconductor packages.
• Conducted cross-sectional analysis and high-vacuum plasma sputter coating.
• Conducted micron-scale SEM imaging and EDS/EDAX analysis of semiconductor packages.
• Characterized polymer resin characterization with DSC and delivered PowerPoint presentation to R&D and manufacturing team members.

Bachelor Of Science (B.S.), Chemical Engineering

Activities and Societies: AIChE, SHPE

Biology, General