• Professional experience in Medical Device Industries with hands on experience in several areas such as: Cost Analysis, Equipment Validation, Investigation Reports, Lean Manufacturing, Process Improvement, Six Sigma, Statistic and Work Measurement• Experience Working with Manufacturing, Facility, and Quality Control design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities • Experience in manufacturing, quality and validation engineer within Medical Device & Diagnostic Industry with products include orthopedic implants, medical instruments, surgical devices and sterilization system and nec-essary consumables used in it. • Proficient in understanding on FDA 21 CFR 820 regulations, ISO 13845, SDLC validation process, design con-trol principles, statistical techniques, Six Sigma, Minitab, Lean manufacturing.• Develop / Review / Execute of Validation Plans (MPVP), User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Design Review (DR), Validation protocols / reports (UAT/IQ/OQ/PQ), and Summary reports in compliance with FDA. • Expertise in writing / developing Test Criteria, Test Procedures (TP), Test Summary Reports, Traceability Ma-trices, Standard procedures (SOP), Work Instructions (WI), Device History Records (DHR) & Inspection Pro-cedures (IP). • Adequate knowledge of various manufacturing techniques: Machining, Plastic Injection Molding, Rapid Proto-typing & fundamental knowledge of Pneumatics. • Strong understanding of process excellence methodologies & process capability studies. • Demonstrate competencies on Corrective Action & Preventive Actions (CAPA), Non-Conformances, root cause investigation through fishbone analysis, process flowchart, fault tree analysis, five whys, control charts etc., • Point of contact to client for Supplier & offshore and manage estimations, executions, monitoring.

• Software: Minitab,, Solidworks, and Microsoft Word, Excel, PowerPoint, Project.• CAPA Engineer handling process development, root cause analysis, and process implementation• Validation (IQ, OQ, PQ), Quality Improvement Process (QIP), and supporting Good Manufacturing Practice (GMP)• Familiar with Quality System Requirements (21 CFR 820, ISO 13485, and FDA regulatory compliance) • Six Sigma tools utilization to improve process capability (CPK, PPK) and cost reduction• Familiar with Geometric Dimensioning and Tolerancing (GD&T) principles in print reading & design