PROFESSIONAL SUMMARY:

• Senior Quality and Validation Engineer, and Project Manager who offers 30 years of experience in medical device, pharmaceutical, rail car, document imaging system, and software solution industries.
• Broad background and experience in Design Control, Risk Management, Software / Computerized System Validation, Electro - mechanical System, Post-sale Professional Services, Manufacturing Process and Procedure, Quality System Audit and Improvement with a track record of delivering high quality system and practical compliance solution.
• Developed and reviewed SDLC documentation including but not limited to various project plans, URS, FRS, design specifications, risk assessment, FMEA, traceability matrix, test protocol/specification/report, IQ/OQ/PQ, SOP, DHF, DHR, non-conformance, complaint, CAPA, and regulatory submission.
• I am a certified Scrum Master and Lead Auditor on ISO 13485.

SPECIALTIES:

• Software/ Computer System/ Automated Equipment/ Process Validation, GxP Assessments
• SDLC, Design Quality Engineering, Risk Management, DHF Audit and Remediation
• Process and Procedure Development, Gap Analysis, Quality System Audit and Remediation
• In-coming Part Inspection, Supplier Part Qualification, Device History Record, Change/Deviation Control
• Project Management for complex product development, product launch, and customer support cGMP, GAMP, CFR Part 11, 820, 210, 211, ISO13485, 14971, IEC 62304, Meaningful Use, DIACAP
• Technical experience in Software/Firmware Engineering, Real-time Embedded Control System, Device to Device Communication Protocols, Machine Control and Diagnostics, and User Interface software design and coding techniques, and Localization

EXPERIENCE:

System Validation Consultant

Confidential, Frederick, MD

Responsibilities:

• Contribute to the validation deliverables that includes gap assessment, URS, FRS, Risk Assessment, OQ and PQ test plans and test scripts for a LabVantage LIMS release 8 upgrade.

Senior Software Design Quality Consultant

Confidential, Boulder, CO

Responsibilities:

• Served as the project core team member to provide design control guidance:
• A class II medical device software product development and professional services. The Vital Sync Virtual Patient Monitoring System collects, aggregates, and transmits required data to and from the connected HIS, devices, and databases and provides remote monitoring data display for patients.
• A non-product patient monitor integration tools (device protocols simulator and OEM interface module) development via third party engineering suppliers.
• Led risk management to develop the risk management plan, system hazard analysis and risk assessment documents.
• Conducted quality review of SDLC, 510K, and professional services documentation and record.
• Certified Scrum Master, Polarion ALM, Agile PLM, and Agile software development process and system experience.

Senior Quality Consultant

Confidential, Cleveland, OH

Responsibilities:

• Conducted audit and remediation of in-coming material receiving inspection, supplier part qualification, device history file, and product deviation control quality records and procedures in prepare for the up-coming Confidential audit.
• SAP QM and Agile PLM system experience.

Senior Validation Engineer

Confidential, Telford, PA

Responsibilities:

• Developed and executed system verification plan and report, risk assessment, SRS, test specifications, and RTM for class II medical device software (Innovian Anesthesia ) and non-product Medibus protocol simulator validation.
• Innovian Anesthesia is a medical data management system for collecting, recording, and displaying information from anesthesia system and patient monitors, and hospital information system through HL7 and varies device communication protocols.
• Agile/Scrum software development process, Meaningful Use and DIACAP experience.

CSV/Process Validation Consultant

Confidential, Ann Arbor, MI

Responsibilities:

• Reviewed and revised SOPs for the service and manufacturing process validation for class III Heart-Lung machine, CDI 500 Monitor, and Calibrator products per the consent decree remediation plan.
• Prepared URS, FRS, test plan and protocols for Service Management System (SM-Plus) software upgrade validation.

Software Quality Assurance Lead Consultant

Confidential, Denver, CO

Responsibilities:

• Developed medical device software design control procedures for Confidential .
• Installed and configured PTC Integrity software for Confidential .
• Performed quality reviews of the process FMEA for Confidential .
• Developed and executed test protocols for the validation of Alpha Trust document signing software, and the Confidential document and management software per Confidential policies and procedures..

Computer System Validation Lead Consultant

Confidential, Andover, MA

Responsibilities:

• Led a team to re-validate the Supplier Corrective Action Request System (MetricStream, interface with SAP) to support the Confidential 483 remediation plan.
• Developed risk assessment, URS, FS, validation plan, test scripts, and final report.

Senior Software Quality Specialist

Confidential, Rochester, NY

Responsibilities:

• Supported New Product Development (NPD) teams, IT project teams, and manufacturing teams to develop and validate product and non-product software within regulated environments.
• Product Software: Stellaris, a class II cataract surgery system in 510K submission included a touch screen UI, embedded software, CAN bus, and a bluetooth foot paddle, and the remote service and diagnostic tools.
• Manufacturing Systems: Vision inspection system, automated contact lens manufacturing lines (PLC/SCADA/HMI), shop floor manufacturing execution system, Siemens purified water generation system, miniFiles generator software, mill and lathe equipment, and pipette calibration system
• Non-product Software: PeopleSoft, LabVantage, Liquent InSight for eCTD, Phase Forward electronic data capture and Clintrial, ComplianceWire, Blue Mountain Calibration Manager, and In-house service management system
• Implemented global CAPA, compliant, non-conformance, management, document control, and change control procedures with software rollout across sites
• Developed and reviewed Validation Plan, URS, FRS, DDS, RTM, CFR Part 11 and risk assessments, dFMEA, pFMEA, FAT/SAT/IQ/OQ/PQ protocols, SOPs, and Summary Reports

Rational Software Consultant

Confidential, Rochester, NY

Responsibilities:

• Performed IBM Rational software installation, configuration, administration, and to support 300+ users over twenty projects.

Software Project Engineer

Confidential, Yonkers, NY

Responsibilities:

• Served as the interface between customer and third party suppliers to manage the delivery of rail car custom software/firmware, documentation, and SEI-CMM per contract agreement. Performed software configuration management and documentation reviews using IEEE standards.

Technical Specialist / Project Manager within PMO

Confidential, Rochester, NY

Responsibilities:

• Managed a client-server based print and device management product (PrintXChange) software release plan and the day to day third level customer support.
• Supported new web-based software product development from concept to launch in full product development life cycle.
• Developed VOC, Market Attack Plan, integrated project plan, software requirements, UAT, launch and post launch strategy and deliverables.
• Evaluated, purchased, configured, and administered Rational ClearQuest and RequisitePro.