Led the development and implementation of quality control processes, ensuring adherence to industry standards and regulatory requirements.Performed legacy system remediation qualifications & validations on existing qualified process equipment for manufacturing of medical devices according to 21 CFR Part 820 and ISO13485 guidelines.Investigated and resolved non-conformances through effective Root Cause Analysis (RCA), implementing corrective and preventive actionsEvaluated and completed Product Complaints, CAPA’s, Non-conformance reports, and field actions and if necessary escalated to CAPA’s.Experience using continuous improvement tools, including process mapping, root cause analysis, and FMEA.Developed and updated Standard Operating Procedures (SOPs) to ensure accurate documentation and process consistency.Experienced in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting their mediation plans to mitigate the non-compliance.Used Six Sigma DMAIC methodology for corrective actions and preventive actions.Maintenance of CAPA and NCR files.Reviewed and Designed Functional Requirements Specification (FRS) and Design Specification (DS) documents.Used problem-solving tools like process map, Pareto chart, 5 whys, cause, and effect matrix for root cause analysis.

Worked collaboratively with all departments as Quality Systems by supporting and developing Risk Assessment, CAPA Investigations, Corrective/Preventive Actions, Root Cause Analysis, Planned Deviations, Procedures Revisions, Measuring Instruction Sheet Creation and Revision, performing Health and Hazard Evaluations (HHEs).Developed TMV protocols and reports for routine methods used in the laboratory.Performed first article inspections for new/revised components.Used US and International regulations including relevant parts of 21 CFR 820, 210, 211, 801, EN ISO 13485 and ISO 9001.Supported validation efforts for GxP computerized systems, ensuring compliance with industry standards.Conducted risk analysis and implemented a risk-based approach to qualify GAMP-5 category equipment, ensuring adherence to industry standards like 21 CFR Part 11 and EU Commission requirements.Responsible for root cause failure analysis/ defects investigation.Supported incoming with daily activities and updated the incoming inspection procedure to improve the material inspection controls.Using Six Sigma principles identified key process indicators and developed dashboards to illustrate the KPIs.Gap Analysis includes determining completeness of qualification and validation testing and determining the completeness of supporting procedures as required by their standards.Experience in using MINITAB performing Gauge R&R, ANOVA and creating graphical analysis of products tested.Experience in Technical Writing and Good Documentation Practices.