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.• Inspected manufacturing batch records for verification of Final Release Specifications and identification of Non-Conformance (NC) and Lab Error Reports (LER) relevant to customer complaints.• Analyzed SalesForce.com complaint data and generated monthly trending statistical reports.• Organized inventory of manufacturing retained samples and scrapped expired materials.• Member of 5S Product Support team that organized, developed, implemented, and attained a 5S-Laboratory certification.• Collaborated with CAPA group on corrective and preventive actions.• Gathered complaint data and documentation during federal and internal audits.

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 developing strategic plans and setting priorities on a daily basis.• 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.• Performed daily Quality Assurance (QA) batch record verification in accordance to cGMP standards.• Maintained a clean and safe work environment in accordance with OSHA safe practices.• Effected SAP electronic transactions for completed production orders with precise data collection.• Verified EDOS stream micropipette accuracy via daily weight test and calibration procedures.• Successfully completed Certified Cargo Screening Program (CSCSP) developed by the TSA.

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.• Managed materials inventory and finished product delivery.

-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