SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that product quality adhere to the Quality Management Systems guidelines * Created Quality Management System from scratch and maintained in accordance with ISO 9001 & ISO 13485. * Experienced in ANSI Z1.4 and Z1.9 standards for Variable and Attribute sampling plan methodology * Experienced in creating and monitoring the Inspection System for incoming, in-process, and finished goods. * Experienced in 21 CFR Part 820 (cGMPs/QSRs) * 820.20 Quality Audits * 820.30 Design Control, * 820.50 Purchasing Control * 820-70 Production Process control * 820.72 Inspection, Measuring and Test Equipment * 820.80 Receiving, In-process and finished device acceptance * 820.120 Device labeling, * 820.198 & 820.200 Complaints & Servicing, * 820.100 CAPA, 920.90 Nonconforming Product * Experienced in Verification and Validation process for software and medical devices (IQ, OQ, PQ) * Experienced in IPC soldering standards in accordance to IEC standard 60601-1 Medical Electrical Equipment * Good understanding of Design methodologies (DFSS, QFD, ROBUST Design) * Experienced in Technical Drawings (Blueprints and GD&T) * Good understanding of ANSI/ASME Y14.36 - 1996, ASME Y14.5M-1994 * Experienced in GR&R for incoming material inspection and software testing methods. * Performed RCA on customer complaints and nonconformance. * Test script, Use Cases, Analysis. * Experienced in Clean Room (Production) related activities and requirements. * Experienced in SOP, GMPs, and cGMP * Good understanding of Failure Mode Effects Analysis (FMEA) * Experienced in creating Test Procedures, Inspection Procedure and Work Instructions. * Created, implemented and monitored Supplier Management System, prepared survey, Supplier Classification, AVL, Supplier Certification process. Monitored supplier quality and performed audits. Participation in Material Review Board (MRB) for material disposition. * Experienced in First Article Inspection. * Experienced in Final Quality Inspection. * Created, maintain and controlled Document Control Management Systems * Experienced in Internal and External Audits. * Experienced in Inject Molding (Defects and Causes) Information Technology and Software Quality Engineering: * Experienced in programming Visual Studio. Net, Net Framework, Visual Basic. net, C#, HTML, Java 1.0, JavaScript, Internet Explorer, Visual Source Safe (VSS), XML * Good understanding of IEC 62304 * Experienced in Software and Hardware V&V. Experienced with SDLC w/r to Software Development in accordance with ISO/IEC/IEEE Standards. * Experienced in Requirement gathering and Analysis. * Experienced in System Analysis and Design. * Experienced in Client/Server, 3 Tier/ N-Tier & Web-based applications. * Expertise in MS Access, SQL Server (Relational database Designs & Developed Procedures, Views Cursors & Triggers), Oracle * Developed Crystal Reports, SQL Server Reporting Services * Rational Rose (UML) (Data Modeling, Use Cases & sequences Diagram etc.) * ERP Oracle. (CRM, Quality management) * Experience in writing Test Scripts, Protocols, and Validation Criteria. * Experience in User-Interface, Test Plan, Black Box Testing, and White box Testing, Agile, and Stress Testing.

Highlights:

• Quality Assurance
• Test
• Database
• ISO
• Management
• Manufacturing
• Procurement
• Quality
• Quality Control
• Quality Management
• manufacturing
• production