Developed design risk management documents like Risk Management Plan and Risk Analysis Chart to support New Product Development (NPD).• Identified new & reviewed existing Product Risk scenarios, and prepared Preliminary Hazard Analysis documentation to support new product launch and product change.• Supported Test Method and Test Method Validation preparation and execution for production support and remediation projects.• Supported supplier setup and currently working on completing Production Part Approval Process (PPAP) process for NPD projects.• Met day to day business needs by supporting process changes, product quality improvements, change management process, review and approval of documentation, remediation of documents, Corrective Actions and Preventive Actions (CAPA) activities, Issue Impact Assessment (IIA) activities and non-conforming material report (NCMR) process.• Led CAPA actions as a CAPA Specialist to establish correction, implement corrective actions and preventive actions, complete Product Hold Activities and revise documentation per Quality Procedures.

Worked for Jabil Inc. (West Chester, PA)• Developed and established manufacturing process and process flow to support New Product Introduction for medical device.• Worked on Patient Specific Product Transfer between manufacturing sites and executed validation plan & verification studies to support immediate production/patient requirements.• Validated and re-engineered existing product line with updated manufacturing process & improvements to implement streamlined product flow and improved cycle time to meet increase production demands.• Performed and executed process and equipment validations (Installation Qualifications - IQ, Operational Qualification - OQ and Performance Qualifications - PQ).• Performed Engineering Studies & Process tests and evaluated results to be used for future product/process development.• Performed and executed Packaging equipment validations (IQ, OQ, PQ) for sterile and non-sterile packaging.• Performed Test Method Validation (TMV) on gages for specified inspection methods (custom and generic).• Developed procedures and process documentation for meeting Quality Management System (QMS) requirements, in-house manufacturing documents (Process, Set-up and Inspection Sheets) and align them with Product Quality Plan (PQP).• Created Production Risk Management (PRM) documents and align them with Design Clinical Risk Management (DCRM).• Coordinated with supplier for product requirements and verified supplier documentation & compliance certificates for product release.

Worked for DePuy Synthes (West Chester, PA)• Developed and executed Installation Qualifications at the site to support Equipment Installations and internal machine moves as per production requestSupported and executed reliability and form, fit & function studies on medical devices for NPI projects• Developed and executed Operational and Performance Qualifications to release new processes and improve existing processes.• Performed capability analysis on Minitab to support manufacturing procedure to meet process capability requirements.• Evaluated and processed product obsolescence and discontinuation process for legacy products (product de-complexity).• Created, reviewed and approved Document Change Orders and Manufacturing changes (Change Management).• Led process control and monitoring of Critical to Quality (CTQ) parameters and specifications.• Worked as a part of a CAPA team to investigate and resolve customer compliant for a Bill of Material (BOM) mismatch.