SUMMARY

• Over 5 years of experience as a Validation/Quality Engineer wif emphasis on Product & Process validation and verification, Risk Management and Quality Control.
• Hands on experience wif MDR documentation and project plans using Microsoft project.
• Hands on experience in creating all teh Risk Management (HA, PHA, CEA, PFMEA, DFMEA & UFMEA and Design Control documents (UN to DIR, DIR to DO Trace & DVRT).
• Worked on Root Cause Analysis (CAPA) and used techniques like Cause and Effect Diagram and FTA.
• Extensive knowledge on providing quality engineering support to assess risk, address gaps in compliance and re - validate equipment and processes wifin teh scope of remediation.
• Performed Capability Studies, Gage R&R, Process Characterization using Minitab.
• Experienced wif complaint handling and complaint investigation.
• Strong working knowledge of implementing Standard Operating Procedures (SOPs), Design of Experiments (DOE), Design History Files (DHF) and validation protocols (IQ/OQ/PQ/SQ/TQ).
• In-depth understanding of teh regulations related to ISO 13485, ISO 14971, and ISO 11607, 21 CFR 820 and European regulatory.
• Well versed wif FMEA, DFMEA, PFMEA, Gage Reproducibility and repeatability studies (Gage R&R).
• Successfully executed Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Worked on NPI (New Product Introduction) documentation to include teh equipment in teh calibration data base (CDS) and maintenance data base (MDS).
• Conversant in dealing wif PPAP process, Lean and Six sigma; checking teh BOMs in SAP.
• Solid knowledge of quality tools such as capability studies, Normality test, design of experiment, Control Plans,PPAP& GD&T.
• Experience in providing support in teh development of inspection plans, CAPA, first article inspection, process validation, in-process and final product inspection.
• Good experience in authoring and executing processand equipment validations (IQ/OQ/PQ) for assembly and packaging areas.
• Reviewed and verified Engineering and QA data to insure accuracy of information that uploaded to SAP.
• Experience in generating all validation documents, including Validation Plan (PVP), Gap Analysis, Gage R&R, Design Specifications and DOE’s.

TECHNICAL SKILLS:

Continuous Improvement: Statistical Process Control (SPC), Design of Experiments (DOE), Six-Sigma (DMAIC), 5 S & 5 why’s Principles, Lean Manufacturing, 8D Methodology, Gauge R&R, PDCA continuous improvement.

Risk Management: FMEA’s (PFMEA, DFMEA, UFMEA), Root-cause analysis, HA, CEA, RMP, RMR & BRA.

Process Control: Standard operating procedure (SOP’S), Unit operations.

Software’s: MINITAB, MS PROJECT, MS OFFICE, EXCEL & VIZIO, PLM, Cockpit, Track wise, Gantt chart.

PROFESSIONAL EXPERIENCE

VALIDATION/QUALITY ENGINEER

Confidential

Responsibilities:

• Experience in creating teh Risk Management plan, PMHA, CEA, Hazard Analysis, DFMEA, PFMEA, UFMEA & Risk Management report for Medical Devices as per teh ISO 14971.
• Experience in creating teh UN to DIR’s, DIR to DO trace and DVRT documents for Medical Devices.
• Provided inputs and feedback in developing teh Corrective Action Plan.
• Experienced wif complaint handling technique and worked wif teh complaints team to change teh severities as required according to teh Medical Affairs review and inputs.
• Experience in building Hazardous situations and Sequence to Hazardous situations based on complaints investigation summary.
• Worked closely wif Medical Affairs team to assign/revise Severity and Harms for different Failure modes.
• Literature study and wrote Technical Analyses to justify few User Needs and Design Input Requirements that which are not derived from teh ISO standards.
• Performed Design Verification activities.
• Gained experience in CAPA investigations and closing Nonconformance Material Reports (NCMRs).
• Worked closely wif Supplier's Design team in redesigning few parts to make them ISO compliant.
• Drafted protocols for Non-Clinical Simulated Packaging Distribution Testing.
• Wrote Technical Analyses to leverage old Design Verification tests for teh current use.
• Worked closely wif Design team to update few product drawings to fill in teh Gaps identified.
• Updated Technical File for teh MDF.
• Provided support to teh designated Complaints investigation team.
• Reviewing and approving First Article Inspection protocols as required.
• Created Process Flow Charts using MS Visio.
• Responsible for teh development and execution of Process Validation Plans (PVP).
• Developed and executed IQ, SQ (Software Qualification), TQ, (Tooling Qualification), OQ and PQ protocols for product, processes and equipment wifin teh facility.
• Authored and executed Test Method Validation (TMV).
• Performed GAP Analysis and prepared Remediation Plans to address teh gaps identified.
• Involved in validation process coordination wifin cross-functional departments such as Technical Operations, Engineering, Quality Assurance, and Regulatory affairs.
• Demonstrated Quality tools/methodologies including: SPC, DOE, CAPA, Complaint Investigation, Lean Six Sigma Methodologies, MSA and FDA standards
• Developed and implemented processes consistent wif teh Continuous Improvement System through LeanManufacturing.
• Experienced working wif teh development team and customers to develop production lines and release medical products to market.
• Set up design and development process as per 21 CFR Part 11 & Annex 11, 21 CFR 820.30, ISO14971 & ISO13485 requirements.
• Assisted design engineers in conducting design for manufacturing studies for NPI (New product introduction) and new product development projects.
• Applied knowledge of GD&T and tolerance stacking to ensure high precision gauges meet design criteria.

VALIDATION ENGINEER

Confidential

Responsibilities:

• Gathered business needs and requirements for technical team by interacting wif teh customers.
• Developed User Requirements Specification (URS) document from teh Business Requirements Document (BRD).
• Worked wif teh SAP consultants to learn Engineering and QA related modules in SAP.
• Developed functional test methods for design verification, process characterization using Minitab, process validation, and finished product.
• Support 21 CFR part11/GxP Risk assessment analysis & ensure computer systems and applications compliance wif system requirements, Industry quality standards, GAMP and FDA regulations.
• Developed teh Functional Specification (FS) document for Malvern Mastersizer System wif teh halp of development team addressing all teh requirements of User Requirements Specification document.
• Updated process FMEAs, conducted Gage R&R’s, capability studies to determine root cause and take steps to achieve necessary corrective and preventive actions.
• Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.
• Review/Write and execute IQ/OQ/PQ Protocols for computer systems software validation to ensure that teh system conforms to user specifications and business intended use and functions as expected.
• Created a Validation Master Plan and determined teh scope of teh validation using GAMP V methodology
• Authored in depth IQ/OQ/PQ protocols for Malvern Mastersizer 3000 System to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements.
• Developed Standard Operating Procedures and validation testing to meet CFR Part 11 and Data Integrity requirements for analytical equipment.
• Validated computer systems using cGMP, cGLP and cGCP guidelines & attended weekly meetings to discuss teh status of teh project.
• Responsible for writing UAT test cases for Malvern Mastersizer 3000 System & Developed Traceability matrix & performed Gap Analysis and prepared Remediation plans to fix teh gap identified.
• Used test methods to define and document testing activity that are traceable to requirements & Followed SOPs to halp teh business process in line wif FDA regulations.
• Prepared Validation Summary Report (VSR) to summarize teh overall Validation activities.
• Worked on CAPA investigations and implemented root cause analysis techniques for teh customer complaints.
• Collaborated wif R&D and utilized Design of Experiments (DOE) to construct Test Methods to meet Validation and Verification requirements.
• Used MINITAB for calculating process capabilities, plotted control charts (Cp,Cpk & Pp, Ppk)
• Wrote and approved procedures, risk management documents and engineering change orders in accordance wif company procedures based on 21 CFR part 820 and ISO 1348.
• Updated as required Device History Records (DHR) to ensure that they are fully aligned wif teh procedures in force as well as theDHF(s).
• Referenced DHF’s and DMR’s for test plan execution as per SOP’s for design, installation, operational and performance qualification wif respect to various international medical device regulatory standards.

Associate Quality Engineer

Confidential

Responsibilities:

• Developed and executed validation protocols for qualification (IQ / OQ / PQ) of medical device manufacturing equipment and utilities.
• Supported Risk Management and CAPA through customer complaints / root cause investigations and trending analysis.
• Gained experience in CAPA investigations and closing Nonconformance Material Reports (NCMRs).
• Performed Analysis of Vendor Delivery Effectiveness resulting in improved delivery schedules.
• Oversee multiple suppliers and communicate supplier performance on key quality metrics and teh corresponding continuous improvement plans.
• Collaborating wif design engineering to determine receiving inspection requirements of purchased components.
• Responsible for developing Incoming Inspection and First Article Inspection (FAI) documents.
• Responsible to create, circulate, review and close Supplier Change Request Routes.
• Oversee teh maintenance of Approved supplier List (ASL).
• Conducted design of experience (DOE) on new sealer equipment and packaging system. Performed package testing and troubleshooting of packaging designs and/or processes.
• Update and maintain Validation Protocols, forms and records to meet cGMPs and federal regulatory requirements.
• Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on medical device manufacturing equipment.
• Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying teh acceptability of process capability.
• Performed GAP Analysis and prepared Remediation Plans to address teh gaps identified.
• Developed functional Test Methods for design verification, process characterization, process validation, and finished product.