SUMMARY

• Progressive experience as a Quality/Validation Engineer in product design and manufacturing environment. Developed and performed individualized and group training to maintain quality and regulatory compliance. Experience in Class I and II devices and extensive knowledgeinCAPA process.
• Mechanical Engineer with experience in Lean Six Sigma, Cost Estimation, Quality Control, Continuous Improvement Techniques and Logistics.
• Quality Engineer in Medical Device Industry with expertise in Process Validation, Test Method Validation, protocol/report writing, Statistical analysis, NCRs, CAPAs, Supplier Quality, Design Verification and Equipment qualifications.
• Expertise in supporting validation process by writing Technical Reviews, monitoring and updating Device History Records (DHRs), inspection sheets and master drawings for completeness and accuracy of developing test methods.
• Organized continues improvement and trained workers regarding 5S practices.
• Expertise in processing Engineering change orders. (Development ECO’s & Production ECO’s)
• Ability to apply Gage R&R and statistical tools towards validation and evaluation of measurement methods. Used Minitab software to analyze the data.
• Well - versed with Six Sigma concepts, Statistical Process Control, Design and Process Failure Mode and Effects Analysis (D/PFMEA) and Equipment and Process validations.
• Expertise in writing study designs, engineering analysis and lab study reports.
• Superior knowledge in risk assessment, 21 CFR Part 11 assessment, and reviewingvalidationplans.
• Experienced in preparing and reviewing Test Plans,Validationprotocols (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ) and Test Summary Reports.
• Actively involved in all stages of process validation - Process Design, Process Qualification, and Process verification.
• Experienced in implementation of Change Management/Control. Experienced in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting their mediation plans to mitigate the non-compliance.
• Experienced in evaluation of Manufacturing & Service work instructions and developing a test method to evaluate the risk and validate them. (Functional testing/Risk Assessment).
• Experienced in validating test methods and processes utilized in the manufacturing of medical device products pertaining to medical device regulations including FDA 21 CFR Part 820 compliance and ISO 13485 & 14971.
• Risk Management, DFMEA, and PFMEA support. Product development and operations engineering support.

TECHNICAL SKILLS

Technical skills: Lean, Six Sigma, Lean Quality Tools, Activity Scheduling, Industrial Management, Facility Layouts, 5S, SAP 6.0.

Certification: Yellow belt

Operating Systems: Windows Vista/XP/7/8/8.1/10

Designing Packages: Solidworks, Matlab

MS Office: Word, Excel, PowerPoint, Access.

ETL and Data Analysis: Excel, Minitab

PROFESSIONAL EXPERIENCE

Confidential

Quality Engineer

Responsibilities:

• Responsible for all aspects ofQualityAssuranceactivities for manufacturing and engineering.
• Responsible forvalidationsofprocessesand equipment in accordance with FDA and ISO guidelines.
• Authored and executed IQ, OQ and PQ protocols, and wrote reports summarizing the validationactivities and deviations resulted during execution and their closure with necessary root cause investigation per GMP regulations.
• Wrote, Reviewed and approved Engineering Change Orders and Engineering Change Records, Design History File documents, IQ, OQ, PQ reports for accuracy and correctness.
• Validated Test Fixtures, Test Assemblies and Gauges.
• Equipment qualification included density and stiffness testers, hydraulic leak testers, pull testers and x-ray inspection systems.
• Authored Test Protocols and performed TMVs.
• Ensured Risk Management Plan and Report follows QSR 820 and ISO 14971.
• Performed GAP Analysis of existing Risk Management Plans, Process Documents and suggested Remediation activities.
• Responsible for Creation, evaluation, and validation of product and process test methods.
• Authored test methods for some existing work instructions and developed strategies to validate them
• Experienced in statistical data analysis using Minitab (Gage R&R, Anova studies).
• Prepared detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications.
• Performed Hazard Analysis, PFMEA, DFMEA.
• Handled Product complaints and initiated CAPAs.
• Participated in weekly CAPA Review meetings, managed and issued weekly CAPA status reports and ensured CAPAs were closed on time.
• Identified, justified, and implemented various projects to reduce manufacturing costs, improve processes, increase product reliability, and enhanceprocesscapability.
• Assessed existing Quality ControlProcessesand identified and implemented improvements.
• Participated in project status meetings and provided status updates.

Confidential, Chicago

Intern Quality Engineer

Responsibilities:

• CreatedProcessValidationPlans, ProcessMaps,ProcessRequirements, PFMEA, protocols and reports for IQ, OQ, PQ, and MVP's for remediation of process and equipment.
• Performed Test MethodValidations. TMVs included both destructive and non-destructive testing depending on the characteristic being tested. Performed Gage R&R studies as per company specifications.
• Developed Standard Operating Procedures (SOPs).
• Managed comprehensive tracking sheet for NCMRs remediation activities and the Mastervalidation plan which includes equipment and tools serial numbers, protocols execution progress and verified calibrated equipment.
• Authored and ManagedValidationMatrices, Technical Reviews, PFMEA and Risk Files.
• As required updated Design History Files, Risk Management Files and DFMEA.
• Identified the potential Hazards in the device and addressed them in the RM Plan.
• Reviewed the Device Master Record (DMR).
• Updated as required Device Master Records (DMR) to ensure that they are fully aligned with the procedures in force as well as the DHF (s).
• Performed Incoming Inspections and reported defect findings to supplier.
• Wrote and kept up-to-date ManufacturingProcesssteps and supporting Documentation including BOM's, assembly drawings and procedures.
• Applied LEAN, 5S and TQC (Total Quality Control) to identify/reduce waste additions in production lines, such as motion,process, wait, over-produce, transportation, inventory and rework.
• Authored Visual Work Instructions and Manufacturing Procedures.
• Instrumental in management of supplier Audits, Supplier Corrective Actions SCAR's ECO'S as well as Supplier Process Validations for text fixtures, cleaning, soldering and welding processes.

Confidential

Engineer-MIS

Responsibilities:

• Ensures operation of machinery and mechanical equipment by completing preventivemaintenance equipment on engines, motors, pneumatic tools, conveyor systems, and production machines; following diagrams, sketches, operations manuals, manufacturer's instructions, andengineering specifications; troubleshooting malfunctions.
• Locates sources of problems by observing mechanical devices in operation; listening for problems; using precision measuring and testing instruments.
• Removes defective parts by dismantling devices; using hoists, cranes, and hand and power tools; examining form and texture of parts.
• Manage Fleet Planning.
• Financial Management.
• Information Verification.
• Defect analysis and ensuring maintenance envelope is constantly being reviewed for improvement.
• Resource planning to tie in with fleet schedule