Available for remotely performed projects, only minimal travel. Passport not renewed,

Remotely performed projects, minimal travel. Passport not renewed. R&D duties taught Electronic Systems and Fundamentals, Ultra-Sonics, ElectroMechanics, Airborne Systems, et alFDA QSR relationship/management of Notified BodiesCreation of and Continuous Improvement of Regulatory Compliance and Quality Management Systems Championed Development and Harmonization of Corp. QMS SOP’s for ten site global implementation: 13485/21 CFR 820, Design Control, Regulatory, Risk Management, Process Control, et al. Created the training modules and conducted training. For 10 associated Medical Device Design and Manufacturing sites enabled global market access and compliance via strategic and tactical Regulatory Compliance and QMS harmonization and development of Site Teams integrating FDA QSR/EN/MDD/CMDR Q&R Management Systems & Procedures for 10 global Medical Device Development and Mfg facilities, including: China, India, Israel, Sweden, Ireland, Canada, Mexico, USADistinct CapabilitiesStartup/Turnaround, FDA QSR, EU MDD, International management experience. Directed and Managed Global Quality and Reliability staffs in Ireland, Korea, China, Israel, India, Mexico, Europe, USA, Updates to/rewrites of/creation of/implementation of Quality Management Systems, Design Dossier/Technical Files, Essential Requirements, CE Mark, Labeling, Vigilance, SOP, Design Controls (History, Planning, Changes, Traceability, Review), Training, Risk Management, CAPA, Quality Manual, Validation (process, design, gages, measurement), Quality Control, etc. ISO Lead Auditor-Audit, Gap Analysis, Supplier Development and Qualification, Risk Management and Analyses processes (EN ISO 14971, IEC 62304), Regulatory Compliance Consultant for Medical Software products, Formally trained Technical Report Writer (have presented to Naval Weapons Center and others), Consent Decree remediation, exposure and high-visibility to Sr. Mgt, Failure Analysis, Formally Trained Trainer, Quality Metrics, Statistics, UDI

• Project Manager, Product Development, and Regulatory Compliance for Medical System (Devices) start-up. (Remote)• Business Enterprise Compliance Strategies

Design/Product Validation. Risk, Design History, Validation protocol and report.

Consultant for Medical Software products• SW Compliance Gap Analysis• Executed Software Development Design Control• SW Hazard Analysis checklist and updates to EN ISO 14971, IEC 62304• SW Requirements Specs• SW Product Development Plans• SW Product Requirement Docs

Spearheaded OQ and PQ for Process Validation

• Interface with key stakeholders and outside experts/vendors to define product requirements.• Fleshed out, established, and executed retrospective Design Requirements Documentation, Design History Files, Design and Process Risk Analyses (dFMEA, pFMEA), Product Risk Management.• Reverse Engineered 3 product families for compliance and manufacturing transfer/scale-up

New and different or tried and true - I enjoy them all. Prefer to stay in Medical Device Regulatory Compliance arena but any ISO QMS challenges are suitable.Advised Consulting Firms included Bain and Company, Chicago Consulting Group, Boston Consulting Group. Dispensed training, guidance, direction, expertise, and documentation in the following areas: • Direction for Quality Management and Regulatory Compliance systems in local and multi-site multi-national environments• Typical contractor activities in QMS, RA/QA, R&D, Manufacturing, CAPA/Complaints• Design Controls, Validations, Risk Management, Outsourcing Risks, Headcount And Spend• Overview and organizational structuring for safety vigilance and surveillance • Metrics - KPI (Key Performance Indicators): Quality, Delivery, Safety, Cost

13485/FDA/CMDR Audit/Gap Analysis for Design Control, Validation, CAPA effectiveness, Mfg. ProcessesCatalyzed correction of and creation of procedures that eliminated 35 Design Control policy and procedural deficiencies.

TEC (Tyco Connectivity) - Extrusion Systemsand Zimmer - Cleaning Systems

Produced 70 Engineering documents: released 28 Design Requirements (DRD - Requirements Traceability Matrixes), 26 Design FMEA’s (dFMEA), and 3 Application FMEA’s (aFMEA) assuring compliance to the Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC as well as EU Regulation 793/93 EN62366 regarding evaluation of the biocompatibility risk associated with Phthalates.

Developed Master Validation Plan, Division SOP's, Work Instructions, and procedures for all validations (process, equipment, computer systems, test and inspection methods, facilities, etc.) for multiple divisions and sites.

Validations and Quality Compliance. Developed procedures, work instructions, protocols for process, test method, and equipment validations. Supported validation planning for support of international supplier validation effort. Assembled training modules for various validation requirements, such as IQ-OQ-PQ.Spearheaded critical Compliance/QA/RA Remediations needing Best-In-Class conclusions. Concentrated on QSR/MDD compliant process and test validations. Developed compliant Process, Equipment, and Methods validation procedures and forms (GMP/GAMP)Catalyzed execution of 80 plus compliant validations protocolsCompleted first 2 validations, reviewed and approved protocols and reports executed by Validation Engineering TeamFacilitated validation of Field Service and Supplier test fixturing (Germany, China, India)

Engaged to resolve issues jeopardizing company operation and survival, including ISO 13485:2003 compliance and business relocation. All goals achieved.Executed duties previously carried out by two VP's, a Director, and staffComplete documentation and implementation of FDA/MDD QMS SOP’s and WI’s, performance metrics, Quality Manual, etc.Achieved all critical objectives in two months resulting in ISO 13485:2003 Registration! Performed Regulatory Affairs duties that covered the EU, South America, Canada, Asia, So. Africa

Resolved compliance turnaround issues threatening business unit operation and survival. Provided Regulatory Compliance Training Modules to Corporate.Completed FDA/ISO compliance and transfer of technology and manufacturing to domestic and offshore sites. Supported Accellent corporate SOP compliance harmonization, managed Document Control. Provided needed training and validation guidance to transfer sites.

Championed development of Leadership Teams in the integration of FDA QSR/EN/MDD/CMDR Quality and Regulatory Management Systems and Procedures for ten worldwide Medical Device Product Development and Manufacturing facilities, including: China, India, Israel, Sweden, Ireland, Canada, Mexico, and USA.• Championed Quality and Design Control compliance efforts for major multi-site Medical Division product development (software, electrical, mechanical, and electronics), Product Transfer-Scale-Up, ISO 14971 Risk Management, and medical system software compliance• Originated compliant Quality Plans and Essential Requirements Documents for state of the art Class II and Class III Medical System Development projects. • Reviewed/approved all Engineering Changes• Performed Hazard and Risk Analyses for new medical systems and devices • Customer/Supplier Compliance/QA/RA interface for Med Device System development (Endoscopy, Electronics, SW)• Project Managed Development and Harmonization of corporate QMS SOP’s for global implementation: ISO 13485, FDA QSR, Design Control, DHF, Regulatory, and Process Control. Created the training modules and conducted training.• Documented and executed Software - Product - Process Verification and Validation (IQ-OQ-PQ) protocols for compliant medical device equipment test systems

• Created and drove Quality and Reliability Initiatives in seven USA, European, and Asian ISO 9000 certified facilities and global partners that included Japan, Korea, China, Ireland, Netherlands, and USA.• Partnered with R&D and Manufacturing in troubleshooting of technical mishaps on global scale.

• Championed Regulatory Compliance and Quality Management System implementation in start-up/ growth environment• Spearheaded medical device compliance for design (including electro-mechanical systems), testing (including 60601), UL- CSA listing, and international standards• Prepared Tech Files, Vigilance procedures, Essential Requirements Documents for compliance• Catalyzed Hazard and Risk Analyses for all medical systems and devices• Integrated QSR/MDD compliance provisos into Product Development, Manufacturing, and Support Ops, whilst sustaining robust creation and manufacture of Medical Devices, Systems, Equipment, and Accessories

Headed up all Quality activities literally on a shoe string during tempestuous start up years. Principal QAM, QE, FA Engineer, tech writer.

Managed and coached staff of 40 Reliability and Quality Engineers, Quality Assurance