As a Sr. Quality Validation Engineer/Consultant 7 years industry experience in highly regulated environment (FDA Part 11, 58, 210, 211, 820, GLP, GCP, GMP, and GAMP 5),centered on compliance and delivery of high quality risk assessment, design implementation, validation and maintenance solutions.
Experience in generating all validation documents, including validation plan, Gap Analysis, Remediation Plan, URS, FRS, FAT, PFMEA, Risk Assessment, Design Specifications, IQ, OQ, and PQ Test Protocols, Traceability Matrices, Test Method Validation, DOEs, Standard Operating Procedures (SOPs), and Validation Summary Reports.
Experience in planning and execution of Validation Master Plan (VMP), specifying requirements (URS/ FRS), Design Specifications (DS), creating protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), creating Requirements Traceability Matrix (RTM), and writing Validation Summary Report (VSR).
Has participated in various training to update the latest Medical Device technology
Experience in documenting all phases of system life cycle as required by FDA regulations.
Strong experience in implementation of Change Management/Control and Corrective Action and Preventive Action (CAPA) procedures.
Own and execute assigned NCR, SNCR.
Developed Test method validation protocols (TMV).
cGMP/GDP/GLP Compliance ISO 9001, 13485, 21 CFR 820
Experienced in maintenance of Electronic Records and Signatures and their restricted access
Deep understanding of GxPs including GCP, GMP, GLP and GAMP 5 and their proper implementation
Working knowledge of the industry standards like ISO 9000, ISO 9001, ISO 13485/14971
Ability to work in a multidisciplinary team and problem solving skills.
Impressive Analytical, interpersonal and communication skills.
EDUCATION: Bachelors in Mechanical Engineering, California University 2011.
Arthrex Medical Center, Naples, FL November 2017 – Till Date
Sr. Medical device/Quality Validation Engineer
Develop, implement, and maintain IS13485, MDD 93/42/EEC Annex II, Cal FDB, Medical Device Regulations and 21CFR Part 820 compliant systems for a variety of medical device companies
Perform and support internal quality system audits and supplier audits as a co-auditor
Draft internal audit schedules and compile audit reports based on documented nonconformities and observations
Provide on-site support for external audits (TUV Rheinland, GMED, FDA, and FDB) including being the designated CAPA and internal audit subject matter expert for a TUV audit
Draft responses and planned corrective actions for notified body audit nonconformances
Develop and draft Document Control, Design Control, and Complaint process procedures compliant tIS13485, 21 CFR Part 820, and other regulations
Review and approve lot history records tensure compliance tGMP and internal procedures
Investigate customer complaints for Class I and Class II devices, including making reportability determinations for USA.
Create, and maintain asset allocation in project planning software development standards.
Manage CAPA systems: review CAPA documentation, organize meetings with CAPA owners, and manage deadlines with CAPA owners and management
Act as CAPA owner: Investigate and perform root cause analysis, implement corrections and corrective actions, and pass effectiveness check criteria
Initiate both supplier- and manufacturing-related Nonconforming Material Reports (NCRs) and complete investigation of the nonconformance, root cause analysis, and material disposition
Implement cleanroom processes and maintain Class 8 cleanrooms per IS14644
Monitor product sterility and cleanroom environment through the maintenance of Excel spreadsheets
Manage equipment controls, including scheduling calibration/PM, performing installation qualifications, and resolving out-of-tolerance issues
Perform quality inspections for incoming components and materials for AAA stent with tools such as calipers, gauges, and inspection microscopes
Review and approve lot history records tensure compliance tGMP and internal procedures
Support validation project protocol development, execution, and report drafting for laser welder and software development standards.
Maintain Technical Files for Class I and Class II ophthalmological devices, including updates for IEC 62366 Usability and IS62304 Medical Device Software Development compliance
Support IEC 60601-1, IEC 62304, and IEC 62366 compliance testing project for OCT scanners and software which required constant communication with TUV-Rheinland testing facility
Support timeline and quality plan creation for the transition from IS13485:2012 tIS13485:2016
Maintain Risk Management Files per IS14971 for Class II diagnostic devices: lead project tupdate risk analyses and risk reports tmaintain compliance and current product information
Assess risk acceptability when investigating complaints, CAPAs, and NCRs
Boston Scientific - Maple Grove, MN June 2016 – September 2017
Medical device/Quality Validation Engineer
Responsible for all validation requirements including Test Method Validations, GR&R, DOE, Software development standards.
Quality Engineer on team for commercial medical device to support the annual product review, process scale up, continual process improvements utilizing the change control process
Responsible for developing, implementing and updating quality procedures, work instructions, installation, operational and process (IQ, OQ & PQ) validation protocols and plans, ensuring regulatory compliance with cGMPs of all medical devices regulatory agencies (i.e. FDA and ISO).
Retested defects with the release of every new version of software development.
Collaborates with cross functional team to develop equipment validation protocols and reports while managing the execution of risk analyses utilizing process and design FMEAs and Master Validation
Facilitated and assisted with the execution of the Internal Audit Process in accordance with ISO 13485:2003 & FDA Quality System Regulation (21 CFR 820) standards.
Performed gap analysis, tracked qualification progress, and revised product labeling & IFUs to IEC 60601/61010 FDA
Supported the Material Review Board to disposition NCMRs, investigate root causes and confirm
appropriate CAPA actions have been completed
Led complaint handling investigations for a commercial medical device and responsible for implementing electronic Medical Device Reporting and FDA Adverse Event Reporting Systems to
Reviews and approves document change requests for Quality Assurance and responsible for evaluating the potential impact on validations and verifications
Responsible for trending manufacturing metrics, lot release metrics, and environmental monitoring
Performs Material and Service Supplier Audits per ISO 13485, 21 CFR Part 58, 210, 211
Atrium Medical, Inc - Merrimack, NH October 2014 – April 2016
Quality Engineer/Validation Consultant
Validated analytical laboratory equipment such as GC, HPLC, Autoclaves and Incubators in compliance with FDA regulations.
Quality Management Support Activities (QMS), Control Plans, Qualifications, Process Validations, gage R&R's along with Design Verifications and Design Reviews, and implementation of new manufacturing processes for new products
Member of the team implementing the FDA mandated UDI identification.
Worked with Validation in developing/writing a Validation Plan, SOP's and Work Instructions.
Authored and executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) scripts.
Defined execution of Equipment Qualification, Test Method Validation (TMV) and Process Validation Protocols (IQ, OQ, PQ) and reports.
Updated and Maintained DHF (Design History Files) in Design Record System.
Validated the Change control Forms for QA and Production moves and ensured the overall risks of all the transports met the Business Criticality.
Gathered Traceability Matrix and performed Gap Analysis in order to meet the User Business Requirements and identified Risk Assessment for all the requirements.
Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation and participated in preparing the implementation plan.
Establishing & monitoring the processes for Issue Management, Change Management and Quality Management.
Neuronetics, Malvern, PA March 2013 – September 2014
Validation Analyst Consultant
Performed User and Business Requirements analysis to prepare Validation Master Plan.
Traceability Matrix (RTM) for the application.
Wrote SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11and GLP requirements.
Performed System testing and documented results as part of IQs, OQs and PQs.
Developed Test plan and written several test scripts for validation testing.
Developed Validation Summary Report (VSR).
Wrote GAP Analysis report and Remediation Plan document.
Medical Product Laboratories Inc, Philadelphia, PA August 2011 – February 2013
Designed procedures and test methods which comply with business, Regulatory, FDA, and industry best-practice guidelines: FDA 21 CFR Part 820 and Part 11, ISO 14971 and 13485, cGMP, GAMP4.
Developed validation documentation (Requirements; Design Specifications; Risk Assessment; IQ, OQ, PQ; RTM, and Reports) for manufacturing processes, systems, and equipment.
Supervised and participated in the implementation of quality assurance procedures and test processes.
Identified and assessed impact of Change Control activities for validated equipment, software, and systems.