Stuart R. Email & Phone Number

• Project Leader and author of a product remediation and new product development Risk Management and Design History File consolidation project by management of design controls for a world market leading manufacturer of SARS antigen test kits (In Vitro Diagnostic Product). • Author of all product Risk Management File documents • Developed Design Inputs including Risk Control Measures and created appropriate design outputs.• SME Leadership of a product/component design team located in Xiamen, China.• Review and remediation of verification files for the IVDP, packaging, shipping and storage.• Reviewed adequacy of Design Verification and Validation.• Implemented regulatory requirements of 2017 /746 EU (IVDR) and the FDA template for Emergency Use Authorization for In Vitro Diagnostic product to address the SARS pandemic. • Defined and translated user needs into technical requirements, and traced through to design outputs, design verification and validation. Completed comprehensive Trace Matrix. • Managed cross functional team responsible for design control and risk management • Advised clients on Design Verification/Validation activities and implemented best practices to comply with FDA regulations and ISO 2017/746 standard relating to In Vitro Diagnostic products.• Implemented product design risk reviews and drove risk mitigation into design requirements and design verification and validation. In compliance with ISO 14972 (2019).• Author of technical documents such as user needs, Engineering Inputs, and Design outputs.• Performed internal and 3rd party audits of Risk Management Files, Design History Files and Design Control Quality Systems• Team leader for and author of multiple high profile Health Hazard Assessment reports.• Directed statistical and complaints analysis, risk management file review and update tasks. • Author of Hazard Analysis reports for review and approval by an executive management review board before submitting them to the FDA.

Consulting at Pfizer Global Supply, Peapack, NJ. Technical Subject Matter Expert Design Controls and Risk Management, Project Leadership team • SME and Project Technical Leader of 26 Design History File remediation projects for Pfizer Global Supply, a world market leading vaccine, drug, and combination product manufacturer.• Risk management/analysis associated with design, usability, and production to ISO 14971:2019 and related to combination products comprising vaccines/drugs and delivery devices. • Leading multifunctional teams through the design and development process, from development of user needs to engineering development, design review, and verification and validation testing.• Responsible for the maintenance of requirements trace matrices and preparation of DHF documents• Research of pharmacovigilance data and preparation of product design risk management reports.• Responsible for the technical review of the work output and mentoring of 8 project Engineers.

Project Leader and Principal Consultant at Ischemaview, San Francisco, Ca. • Quality Engineering Project Leader, taking multifunctional teams through the design and development process for Software as a Medical Device and for combination medical device products. Including user needs, engineering development, design review, and verification testing.• Responsible for assembling the content of all documents in the Design History File.• Responsible for managing project planning documents and the project schedule. • Chairperson of product phase/technical design reviews. I publish minutes and close out actions.• Responsible for auditing project design history files for compliance, traceability, and completion• Software Risk management/analysis associated with design and usability to ISO 14971:2019• Responsible for software validation protocols and reports, including regression analysis.

Consulting at Phillips and TEVA. • Project Leader of 3 Design History File remediation projects for TEVA, a world market leading generic drug and Combination Medical Device product manufacturer.• Risk management/analysis associated with design, usability and production to ISO 14971:2012 and related to drug/device combination products and vital signs monitoring systems. • Design, writing, installation and training of procedures and templates for a completely new Quality System for principal contract manufacturing organizations and recent acquisitions in Europe.• Leading multifunctional teams through the design and development process, from initial concept and development of user needs to engineering development, design review, and verification testing.• Responsible for the maintenance of requirements trace matrices and preparation of DHF documents• Research of pharmacovigilance data and preparation of product design risk management reports.• Providing direction for client with responses to New Drug Application questions from the FDA.• Design History File remediation by management of design controls for Becton Dickinson. Design and manufacture of surgical bactericide application products.

Contracted at Fresenius Medical• Project Leader of 3 product improvement and Design History File consolidation projects by management of design controls for a world market leading medical device manufacturer• Author of entire Design History File for 3 products within a requirements trace matrix database.• Defined and translated user needs into technical requirements, and traced through to, design outputs, design verification and validation.• Managed cross functional product design reviews, as organizer, chair, and scribe.• Reviewed adequacy of Design Verification and Validation against product design, regulatory submissions, manufacturing methods /process validation, and product labelling. • Advised clients on Design Verification/Validation activities and implemented best practices to comply with FDA regulations and ISO standards. • Implicated product design risk reviews and drove risk mitigation into design requirements and design verification and validation. • Author of technical documents such as user needs, Engineering Inputs, and Design outputs. assignments and presentations to communicate plans and results to a technical team. • Supported internal and 3rd party audits of DHF and Design Controls

Quality systems site lead for a team of quality systems engineering consultants. Implementing best practices and state of the art quality systems for world market leaders of medical device products.Director Quality Assurance• Management of staff of 22 quality engineers and client team lead for 6 accounts. • Project manager on both client and in-house projects with complex scientific and engineering requirements, while maintaining project schedules and budgets. Projects included:- o CAPA system remediation, Project manager on a large and Multi Site CAPA system remediation project. Managed 44 CAPA Engineers and over 150 CAPAso Managed Independent reviewer project for over 100 design history files for market leading orthopedics device manufacturero Management of Global harmonization project for quality system of leading orthopedic device manufacturero Multiple implementations of new/retrofit design control processes within medical device and engineering companies to meet regulations established by the FDA and regulatory agencies.o Management of a process validation program to validate 135 manufacturing equipment assets for a prominent orthopedics device manufacturero Providing strategic real time guidance to clients actively engaged in FDA audits and in receipt of 483’s / warning letters from the FDAo Management of a major design history file remediation project for a major cardiovascular device manufacturer that included 16 product design history fileso Performing mock FDA audits to prepare clients for the real thing

At management grade level for 11 years I was responsible for the following. •Design control class III automatic defibrillator medical devices.••Management of site CAPA system as site CAPA Board Chair. Identification and initiation of corrective and preventive actions. Review and closure of CAPAs including effectiveness testing. •Management of site complaints handling unit and internal auditing team comprising 9 employees. Responsible for review, trending and reporting of customer complaints.•Global Management of quality assurance and regulatory compliance activities on new product development teams, including preparation of technical files, STED files, and CE marking applications. •Performing internal audits to ensure compliance to regulatory or corporate standards including ISO 13485. •Management of customer complaints and supplier non-conformances. Performing root cause failure investigations. •Member of site audit teams during FDA site audits that took place 2005, 2006, 2007, and 2012.•Lead Supplier auditor responsible for quality system audits and supplier corrective and preventive actions.•Component qualification testing and acceptance activities for new supplier components.•Risk based management by design reviews, product risk analysis and design FMEAs.•Design of improved quality systems such as change control, CAPA, complaints, Internal auditing. •Supervision of process validation and product verification activities. •Interviewing, selecting and hiring quality assurance and engineering personnel. Training employees, planning and directing work products and conducting performance appraisals. •Subject matter expert /team leader in the 2008 implementation of SAP as the new enterprise management system.•Managed preparation of material for / presented material at management review meetings.•Preparation and analysis of quality metrics for executive management team and Board of Directors.

Fremont , California

•Management of the design, installation and validation of an ISO 5 standard clean room aseptic filling/finishing suite, including automated and manual product filling, HVAC, particle monitoring systems. •Management of validation of manufacturing and quality control equipment, and facilities equipment and processes. •Review and approval of SOP’s for clean room gowning, EM monitoring, equipment cleaning, handling, and storage, manufacturing methods and batch production records.•Design of operating procedures for electronic records and signatures (21CFR part 11).•Design and implementation of the new site CAPA and change control systems.•Chair of the site CAPA review board and Site CAPA Manager.•Responsible for the design and approval of Validation Master Plans, strategies, schedules and budgets for the validation of pharmaceutical manufacturing equipment and processes.

Belmont, California

•Departmental Manager and team leader in the design, construction and validation of 3 separate clean room manufacturing facilities for the manufacture of medical device products. •Directed the strategic development of a new products Manufacturing Engineering department. Recruited, managed, developed and coached a team of Manufacturing, Industrial, Software and package development engineers dedicated to the design and validation of manufacturing equipment, processes and facilities to meet FDA cGMP regulations.•Utilization of Process Flow Diagrams (PFD), and Failure Modes and Effect Analysis (FMEA) and statistical methods to troubleshoot and resolve equipment issues and study critical nodes for process characterization, optimization and validation. Directed and reviewed the validation of software used to control manufacturing equipment.• Management of the design, transportation, commissioning, Installation, and Operational and Performance Qualification testing (IQ, OQ, PQ) of medical device manufacturing equipment.•Statistical techniques including Design of Experiments (DOE), t-tests, f-tests, sum of variances, correlation tests, gauge RnR studies, cp and cpk analysis.•Created bills of materials, detailed project plans and schedules, equipment design documentation, experimental protocols, and maintenance and calibration procedures.•Management of departmental budgets, resource planning, training programs for personnel. •Design for Six Sigma (DFSS) techniques utilized to reduce time to market for new products.

Milpitas, California

•Team Leader of Engineers and Operations professionals tasked with the design, assembly and validation of a production line for a new electronic blood glucose monitor system.•Author of project plans, project schedules, and design transfer plans. Lead author of Manufacturing Process Requirements documents, Process Failure Modes and Effects Analyses.•Design of production line validation plans and protocols to validate a production line to FDA cGMP requirements. Preparation of IQ, OQ, and PQ protocols and reports.•Responsible for the development and qualification of new or modified processes and components, specification of process or handling equipment requirements.•Six Sigma / Black belt techniques utilized on new product and process improvement projects.•Managed production of sub-assemblies by contact manufacturers, including validation and scale up to production.

California, Usa

Johnson and Johnson is a Class 2 medical device manufacturer, which is regulated by the Food and Drug Administration (FDA), follows Good Manufacturing Practices (cGMP) and is ISO 9001 certified.Designed and installed manufacturing processes for manufacturing and packaging of medical products and high quality skin and hair care products to FDA cGMP standards.•Planned and directed equipment installation projects, prepared and managed corresponding budgets. Design of tools and equipment. Administered qualification and validation of new manufacturing processes. Negotiated with, selected, and managed contractors and suppliers.•Leader of two Manufacturing Systems problem solving teams and responsible for the reengineering and redesign of manufacturing facilities. Annual savings $2.8M utilizing kanban technology and “just in time” materials delivery to achieve lean manufacturing goals.

Southampton, Hampshire, United Kingdom.

Engineered manufacturing facilities for the production of military equipment, pressure vessels, printed circuit boards, mineral insulated cable, compressed gas bottles, electric irons, coin metering devices, nuclear fusion reactors, and railway vehicles

Certifed Lead Auditor

ISO 9001:2008 and ISO 13485:2003 Lead Auditor Certification

Bachelor'S Degree, Design And Manufacturing Engineering

Bachelor of Science Honors degree in Design and Manufacturing Engineering

Education record

Bsc (Hons) And Postgraduate Diploma, Design And Manufatcuring Engineering, Industrial Studies

High School/Secondary Diplomas And Certificates