Responsible for supporting manufacturing operations, improvement projects, and solutions. Provided engineering support, troubleshooting equipment/process issues, and assisted maintenance personnel. Supported new product introductions with advanced process design and cost-effective production methods. Drove continuous improvements in machine availability. Developed processes/equipment for medical devices meeting ISO 13485 & 14971. Owned/approved Change Control Management records for product changes within the Quality Management System. Monitored in-process inspections, documented activities, and maintained procedures. Proficient in Design Control, Risk Management models (ISO 14971, 13485, FDA's Quality System Regulation). Utilized data-driven approach for root cause analysis. Developed preventive maintenance procedures, coordinating with cross-functional teams for process validation, and compliance. Participated in material review boards for non-conforming products. Executed CAPAs/NCRs related to manufacturing issues, and performed statistical data analysis. Wrote protocol reports, and updated Product Design History File. Determined root causes and implemented appropriate CAPAs for manufacturing exceptions: supported product launch, design reviews, risk management, and DHF maintenance.

• Supported manufacturing operations in process development, tool design, equipment acquisition, layout, and engineering support.• Drove continuous improvement and optimized manufacturing processes for cost reduction, efficiency improvement, and increased yields.• Troubleshot daily manufacturing and quality issues, recommending and implementing solutions.• Designed SolidWorks jigs and fixtures for equipment validation and production operations.• Led internal quality audits, root cause investigations, test studies, and improvement projects, implementing corrective actions.• Experienced in ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, and other relevant standards.• Provided guidance on quality system documentation to quality assurance personnel.• Reviewed, updated, and revised detailed standard operating procedures (SOPs) and filed change requests.• Collaborated with customers on Change Management requests, aligning procedures with ISO/FDA standards.• Repaired and set up equipment, developed production processes, and preventive maintenance procedures.• Conducted Gage R&R studies, involved customer input in Design Control Documentation.• Monitored, maintained, and controlled the QMS under ISO 13485 standards.• Developed value-added processes, authored work instructions, and coordinated implementation according to LEAN and cGMP principles.• Utilized statistical tools (Six Sigma, SPC) for process characterization, analysis, control, and validation.• Managed CAPA and NCR files, tracking and reporting trends.• Conducted Risk Analysis and wrote Issue/Event Based Risk Assessments, Risk Evaluations.

• Developed manufacturing processes, layouts, and tooling to support new product introductions.• Authored Test Method Validation protocols/reports and IQ/OQ/PQ protocols/reports for manufacturing equipment.• Implemented 5S and Lean principles, applying Kaizen strategies to improve operating standards.• Assisted in cause identification and problem resolution for production or service-related issues.• Provided engineering input for equipment/process design, fabrication, installation, validation, and qualification.• Collaborated with Product Engineering on engineering documentation for New Product Development.• Conducted root cause analysis and implemented CAPAs.• Performed diagnostic and statistical analysis to improve product quality, process reliability, and cost.• Conducted timely studies, Gage R&R, and capability studies for new processes/products.• Collaborated with various stakeholders and complied with ISO 13485 standards.• Utilized knowledge of quality technology, statistics, and applied technology for practical solutions.• Maintained awareness of quality improvement and product opportunities, suggesting and testing ideas.