Quality Engineer Manager

George J. Marcel

** ******* *****, *********, ********** 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 1

Professional Summary:

Quality management, engineering, and systems professional leading and collaborating on quality, compliance, and improvement processes. I am focus on value added solutions through fulfillment of compliant and efficient (lean) systems for customer, regulatory, and business needs. Experienced in both strategic, and hands on tactical quality initiatives applied within multiple industries and numerous product / service scenarios through using good / best practices. Thirty plus years of practical, pragmatic, and broad multiple industry business expertise, I am a quality subject matter expert providing solutions in defining (system architecture, process flow, and problem analysis), implementing (i.e., initial research startup, project, commercialization, growth, or compliance remediation), and monitoring / auditing progress in maintaining product, process, or system applications with continual improvement approaches. Skilled in business processes collaboration for range of organizational structures - virtual, start up, clinical / pre-commercial, and commercial growth to production scaled manufacturing / service system requirements, focusing on appropriate and lean methodologies. Emphasis on practical approaches to mitigate issues and improve processes by leveraging understanding and training to facilitate change.

Experienced in product quality and reliability engineering practices through coordinating innovation efforts and development processes for marketing / human factors, customer use case requirements, research, development, clinical affairs, design assurance and design control projects.

New product introduction quality lead with implementation experience defining and establishing process control and improvement, supplier development management, and risk management

/analysis, design safety, use case, process risk, and related mitigations including post market feedback / updates.

ASQ Professional Certifications – 15+

ASQ – CMQ/OE # 53067 Certified Quality Manager

ASQ – CQE # 103702 Certified Quality Engineer

ASQ – CSQE # 6073 Certified Software Quality Engineer ASQ – CRE # 34819 Certified Reliability Engineer

ASQ – CSQP # 609 Certified Supplier Quality Professional ASQ – CPGP # 798 Certified Pharmaceutical GMP Professional ASQ – CQA # 26842 Certified Quality Auditor

George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 2

ASQ – CMDA # 1358 CBA: Certified Medical Device Auditor ASQ – CFSA # 1751 Certified Food & Safety Auditor

ASQ – CQIA # 10296 Certified Quality Improvement Associate ASQ – CQPA # 2047 Certified Quality Process Associate ASQ – CSSGB # 10603 Certified Six Sigma Green Belt ASQ – CCT # 2680 Certified Calibration Technician

ASQ – CQT # 26320 Certified Quality Technician

ASQ – CQI # 75869 Certified Quality Inspector

Skills & Experience:

I have developed and led QMS implementations – served as director / lead across start up, growth, to remediation correction including training / mentoring programs as manager, instructor, and coordinator. Business / quality systems expertise: FDA-QSR (21CFR820/210/211), Automotive PPAP-ITAF 16949

& Aerospace AS-9000 / Commercial standards as well as latest Medical Device ISO 13485-2003 revision to ISO13485-2016 / MDSAP, EU-MDR/IVDR updates, and general industry, ISO 9000-2008 revision to ISO 9000-2015. Experienced in application of quality system in clinical settings and clinical IRB controls. Prior experience as reviewer for U.S. National Quality Award (MBNQA) with multiple year selections to serve in this capacity.

Quality system architect expertise: Implementation such as project voice of the customer -quality function deployment (VOX/QFD tools) benchmarks including supply chain qualification, process development, and design control deliverables.

Quality projects / Risk Management: risk based (ISO14971 / ISO24971 / ISO 31000) assessments and management including QMS remediation experience for industry compliance corrections for multiple sites. Cost reduction and quality improvement processes. Containment and reduction of internal defects / process updates, resolution of customer site correction and external actions (i.e., notification or recall).

Software Quality projects: Project test plan development and test execution / test lab reviews including standards compliance and/ or statistical analysis as applicable for range of disposable, capital, and IVD products. Software tool use and qualification for quality system incorporation. Led training process and piloting use for function / organizational use and servicing support. Program management for web-based customer and stand-alone product solutions for qualification as well as embedded system test. Defined Agile processes including version, issue, and tracing requirements. Corrective Action /Audit: Coordinated Team based investigation and problem solving (TOPS / 8D / A3) with root cause projects / Corrective and Preventive Action) CAPA process. Experience with George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 3

preventive projects including 5S, DMAIC, and six -sigma tools. Audit and certification / compliance of quality systems to industry standards / customer requirements (Led effort as the company’s Management Representative / Coordinator) Lead auditor and supply chain audits including negotiation/ establishment for multi-million contracts for supplier quality requirements / controls

(including remediation corrective action projects). Regulatory/Clinical Affairs: Customer and regulatory submission experience including Medical Device CE Mark / 510k / PMA manufacturing module coordination. Clinical trial support experience in PMA product, CE Mark / Tech file / EU MDD-MDR transition. Support early concept / NIH studies. Product Submission Materials: Experienced material coordination in support of regulatory submissions for US and EU medical device, and various other industries processes including automotive PPAP

Multiple certifications through American Society for Quality (ASQ), and senior member. Active ASQ local and national program member; I serve as trainer, technical paper reviewer, and session moderator at ASQ industry and national / regional events. Current ASQ -Medical Device Division Northern California Chair and Programs Support roles for local programs sections. Also, member of the Parenteral Drug Association (PDA) West Coast Chapter and its programs. Work History:

Consulting (Contract)

Quality Consultant 1994 – 2018 (part time); 2021- present (full time) Quality Product & Process Services – Part time and Full time projects that are contract based. Consultant /contract assignment per NDA agreements to include strategic and gap analysis, internal and supplier auditing, management system development, innovation customer needs, i.e., definition QFD/ risk management, human factors/usability considerations and projects, QMS planning / architecture, Remediation / CAPA. Provided training programs for various scenarios for organizations and industry groups: Design History Files, Clinical, Regulatory, Software/Systems Verification and Validation Test development and execution; Process Validation, Supplier Qualification and Development projects.

Employment (Direct)

Hologic Breast Skeletal Health / Focal Therapeutics Acquired by Hologic Sunnyvale, California Director – Quality Assurance 2017 – 2020

Overall Quality Assurance and supporting regulatory / clinical projects for growing medical device supplier of commercially available US Class II absorbable biomarker (510k cleared) BioZorb, and US Class I associated women’s health breast cancer products. (Multi-site facility acquired October 2018 and relocated to Hologic Costa Rica facility in 2020).) George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 4

TheraNova, LLC Medical Device Incubator San Francisco, California Director – Quality Assurance 2016 – 2017

Multiple medical device project clinical/spin out company support from design through commercial submission / project company. Support clinical trial & development efforts on project teams and overall quality system structure. (Potrero Medical, Respired, Bone Health, Cognito R, Perikentics, etc.) RenovorRx San Jose, Menlo Park, & Los Altos, California Medical Device Start Up Director – Quality Assurance & Regulatory Affairs 2013 – 2015 Developed Quality Management System and Supplier Controls for outsourced design/processes. Attained FDA 510k clearance & CE Mark for initial novel fluid delivery dual balloon catheter product. Attained California state license (medical device) and ISO13485-2003 certification. Evolved product into combination device in current clinical trials under FDA. IntegenX Acquired by Thermo-Fisher Pleasanton, California Biotechnology Start Up– DNA /RNA Handling & Rapid Human DNA Equipment Senior Quality Engineer 2011 – 2013

Development of formalized quality system processes including meeting product requirements per AS9000 requirements (Northrup Grumman), Forensic (SWAGDAM), etc. Primary Product: RapidHIT ID System. Defined integrated Application Lifecycle Management (ALM) approach for Design Control

(Issue, Requirement, Test Case) for development process including source code management. ArKal Medical Fremont, California

Medical Device Start Up – IDE (PMA) CGMS (Continuous Glucose Monitoring) device Manager – Quality Assurance 2009 – 2011

Defined & deployed quality system including manual, procedures, and supporting docs for IVD product. Support iterative research and design development including all design and process qualification. Attained California State License FDB Approval for clinical IDE application. Keimar, Inc. Device for real-time measurements of blood gas & cardiac output Pleasanton, California Medical Device Start Up; Director– Quality Systems 2009 – 2011 Early phase – bench test/clinical start up defining a novel low-cost device for critical and emergency care. Responsible for developing and implementing quality systems for compliance to FDA 510k/ 21CFR820 QSR and CE Mark/ ISO 13485.

Oraya Therapeutics Acquired by Carl Zeiss Newark, California Quality Assurance Engineer / Quality Systems Architect (Employee #7) 2007 – 2009 Medical Device Start Up – Class II (with special controls) device Established quality system including manual, procedures, and supporting docs for product. Development of document and design controls using PLM (Agile Advantage – Oracle) Support all initial research and design development including defining documented risk analysis and mitigations. Animal study and human concept clinical study; Support capital tool research and design development George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 5

including all design and process qualification documentation as well as supplier outsourced disposable design and development; Conducted and coordinated Internal Audits; Coordinated External qualification for California State License (CA-FDB) and ISO13485-2003 certification. Covidien (Tyco Healthcare) Acquired by Medtronic Pleasanton, California Respiratory Division – Class II & III devices (Worldwide operation support) 2005 – 2007 Manager - Quality Engineering & Validation (2005 – 2007) Division interface for remediation actions, process changes, process validations, design transfer process improvements for all manufacturing locations worldwide. Managed design control & test function support engineering team of nine engineers that included new product development, sustaining engineering, failure analysis, & CAPA for all respiratory products Process Validation QA Manager (International Division level - multi-plant) (2005) Audit lead for design transfer / QSR compliance for recent product releases including evaluation of tooling, product software controls, and integration of risk management. Worked with senior management on FDA warning letter corrections and improvements. Abbott Laboratories (Abbott Diabetes Care (ADC) & TheraSense) Alameda, California Class II & Class III (PMA) medical devices – blood glucose meters and CGMS 2001 – 2005 Senior Quality Assurance Engineer - R&D (ADC) (2004-2005) New Product development quality representative on multiple teams including software development

(website including product data analysis module), meters, and test strip projects. Biocompatibility testing coordination for new product development (IVDD & MDD). Trained new quality engineers during Abbott merger of Medisense and Therasense units. Senior Quality Assurance Engineer (TheraSense 2001-2004) Acquired by Abbott Core team member on continuous glucose meter (CGMS) project including all aspects of design controls from requirements planning, verification/validation testing, risk management, biocompatibility, clinical product release, & documentation support for PMA submission. Developed with process engineering, the pilot manufacturing process including incoming, in process, & final release controls/criteria. Coordinated various quality metrics & design control activities including supplier performance monitoring.

Symphonix Devices Acquired by Med-El San Jose, California

(Class III PMA medical device – middle ear hearing implant) Manager: Quality Assurance 1999 – 2001

Managed the quality assurance function (team of 6 professionals) including inspection, sterilization, CAPA, complaint handling, MDR/vigilance reporting, and design controls. Coordinated quality system management metrics and reviews. Revised incoming inspection process for increased efficiency / requirements compliance. Supported PMA submission; TUV and FDA interface QMS. George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 6

Cardiac Pathways Acquired by Boston Scientific Sunnyvale, California

(Class III PMA medical device - cardiovascular electrophysiology catheter systems) Principal Quality Engineer – R&D 1998 – 1999

Individual quality assurance contributor on diagnostic catheter (PMA) product and other 510k devices. Worked with key suppliers to develop component process capability/ requirements compliance. Manufacturing support for ongoing build including review and dispositioning any discrepancies. Sun Microsystems Acquired by Oracle Sunnyvale & San Jose, California

(Microelectronics Group) Program Manager: Quality Systems (ISO9001) 1996 – 1998 Responsible for developing web-based implementation of a quality system in a fabless design environment for both internal and external Sun customers. Design Control process established for 80 project teams. ISO9000 quality system training for over 900 employees developed and presented. Coordinated training for appropriate quality system tools including team-based problem solving. Guidant (Origin Medsystems) Acquired by US Surgical / Covidien / Medtronic Menlo Park, California

(Class II medical device – minimum invasive surgical kits Senior Staff Quality Engineer 1995 – 1996 Experienced in design control team quality lead including failure analysis, supply base development, in process test development, and product/process improvements. Multiple project design control support and ongoing project support for a variety of single use disposable products supporting minimum invasive surgical applications. Kenetech Windpower (U.S. Windpower) Acquired by GE Livermore, California

(Development, manufacture, & service provider – wind & alternate energy) Senior Director: Product Assurance 1993 – 1995

Responsibilities: Quality Assurance, Product Assurance, Quality Systems, Quality Control, Supplier Quality, Field Services, & New Product Introduction. Attained initial first industry ISO 9000 quality system certification for a wind turbine manufacture, installation, and operations. Developed supplier quality system, on site field triage unit, and internal quality control strategies including supplier certification, component inspection, in-process / final test functions. Managed a department of over 70 plus with annual budget of $6 million in an annual multi-billion dollar sales program. Rockwell International (Automotive Operations) Troy, Michigan Automotive Body & Chassis Systems Senior

Quality Manager: Plastic Products Division 1988 – 1993 Division overall customer quality liaison and manufacturing operations coordination. Facilitated initial commodity GM Mark of Excellence Business Quality System award. Advanced quality

& process improvement programs. Supporting New Product Introduction - International Joint Venture

(JJIAC) - Chrysler/Renault

Injection Molding Industry – Automotive, Electronics, Consumer, Med Device Metro-Detroit, Michigan 1981-1988

George J. Marcel

53 Foxtail Court, Brentwood, California 94513 / Phone (Mobile): 925-***-**** / Email: ********@*****.*** pg. 7

Blue Water Plastics, Marysville, Michigan (1987-1988) Blue Water Automotive Systems – Operations Ceased 2014.

Corporate Quality Manager, Management Representative, & Supplier Management Lead US Plastics, Mount Clements, Michigan (1985 – 1987) Now US Farathane Edwards Industries Business Unit Quality Manager – 3 plant operations – Molding / Electronics Components and Assembly

Mayco Plastics, Sterling Heights, Michigan (1981 – 1985) Now Mayco International Lead Quality Supervisor – 3 shift operations (Molding) / Assembly & Paint Education:

Ongoing continuous education: Professional, business, and technical skills through self-study programs, on the job (OTJ) training, professional seminars, classroom, and ongoing webinar / online – numerous good practice/baseline training.

Online platform programs (i.e., Coursera, MIT, Udacity) Multiple university online programs (i.e., Stanford Bio-Design, WGU, UC-Berkley) Trade organizations, suppliers (i.e., TUV, WuXi, Nelson Labs) Regulated industry training suppliers (i.e., BSI, TUV, AIAG, SPE, PDA) University of California

Berkeley, California

Graduate Certificate: Continuous Improvement for Total Quality University of Michigan

Dearborn, Michigan

Graduate Study: Adult training & development, organizational psychology, industrial sociology Oakland University

Rochester, Michigan

Certificate programs: Statistical quality control (SQC); Design of experiments (DOE) Michigan State University

East Lansing, Michigan

Major: Business – Material Logistics Management (BA), Minor: Engineering Industrial Technology Professional Membership & Related Activities:

American Society for Quality (ASQ) Milwaukee, Wisconsin: Senior Member / 15+ Certifications National Institute of Standards & Technology (NIST) Gaithersburg, Maryland

• Malcolm Baldridge National Quality Award (MBNQA) Examiner (Selected 5 X to serve as examiner) Association for the Advancement of Medical Instrumentation (AAMI) Arlington, Virginia: Member Regulatory Affairs Professional Society (RAPS) Rockville, Maryland: Member Parenteral Drug Association (PDA) West Coast Chapter: Member

Contact this candidate