Kevin Posey, Rac Rcc Mba Cmq/Oe Email and Phone Number
Regulatory Affairs and Quality Assurance Executive Leader | MDR PRRC | Due Diligence for Medtech M&A at
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Genesys Spine
Kevin Posey, Rac Rcc Mba Cmq/Oe's Location
Round Rock, Texas, United States, United States
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About Kevin Posey, Rac Rcc Mba Cmq/Oe
Masters of Business Administration honors graduate (Beta Gamma Sigma), included in first passing group for new RAPS Certified Regulatory Compliance Certification (RCC-MDR) for MDR PRRC (Jan 2024), Certified Regulatory Affairs Professional RAC-Devices (August 23) and RAC-EU (Dec 2013), Regulatory Due Diligence for M&A, Six Sigma Green Belt and Lean Practitioner, Certified Quality Engineer, Software Quality Engineer, Biomedical/Device Auditor, Quality Auditor, Calibration Technician, Quality Technician, and Manager of Quality and Operational Excellence with 30+ years experience in product development and quality engineering as both an OEM and contract manufacturer for the Medical Device, In Vitro Diagnostics, Aerospace/Defense, Industrial Equipment, and Natural Resource industries. 20+ years experience in Medical Device quality engineering, management and leadership in the design, manufacture, and regulatory submission (US and International) support of Class I, II and III devices. Engaging, highly qualified, and experienced trainer in quality disciplines and tools, Root Cause investigation, Corrective/Preventive Action, Software V&V, Computer Systems Validation, and more.Specialties: CSV, Software Quality Engineering/Assurance, Auditor Training, 3rd Party Audit Prep training, Successful Warning Letter and 483 response and remediation, Quality Management and Engineering, Regulatory Affairs, CE Marking, Biomedical Quality Audits, EMS Manufacturing and Quality, Statistical Analysis, Process validation, Supplier Quality Management, Acceptance sampling , ISO9000 Audits, QSR and ISO13485 Audits, Medical Device Risk Management, ISO14971 Audits, Medical Device Design Controls, Injection Molding, Verification and Validation, Device Software V&V, QMS Software Validation, Hardware V&V, 510K and PMA submissions authoring and support, Cardiac devices, Infusion devices, Respiratory devices, Orthopedic implants, In Vitro Diagnostics
Kevin Posey, Rac Rcc Mba Cmq/Oe's Current Company Details
Genesys Spine
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Regulatory Affairs and Quality Assurance Executive Leader | MDR PRRC | Due Diligence for Medtech M&A
Kevin Posey, Rac Rcc Mba Cmq/Oe Work Experience Details
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Head Of Regulatory Affairs And Quality Assurance - DirectorGenesys Spine Feb 2024 - PresentAustin, Texas, Us
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Member, Author, Course Developer, Certification PreparationRegulatory Affairs Professionals Society (Raps) Jul 2012 - PresentRockville, Md, UsProfessional Member since 2012. Developed certification preparation materials for RAC-EU certification and course content developer for RAPS Project Management course. Holder of RAC-EU (2013) and RAC-Devices (Aug 2023). -
Course Developer And ReviewerRegulatory Affairs Professionals Society (Raps) Jan 2014 - Mar 2016Rockville, Md, UsCourse reviewer, developer, and Exam reviewer for RAC certifications (RAC EU in particular), certification preparation courses, and supporting courses such as Project Management for Regulatory Professionals
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Active Member, Section And Division Management/LeadershipAsq - World Headquarters Jul 2006 - PresentMilwaukee, Wi, UsAudit Division Chair (elected), Jan 2020 - Jan 2021Audit Division Chair-elect, Jan 2019 - Dec 2019Audit Division Treasurer (elected), Jan 2016 - Dec 2019Education and Training Chair, Audit Division, May 2014-Dec 2018Innovation Interest Group Co-founder 2009-present, Secretary 2012-2015Quality Management Division Technical Committee, 2009-2013Pittsburgh Section Programs Chair 2011-13 Pittsburgh 2012 WCQI Conference Site Planning CommitteePittsburgh Biomedical Discussion Group co-founder 2008-09Dallas Section Programs 2006-07Member since 2006 -
Head Of Regulatory Affairs And Quality Assurance (Director Level)Monogram Orthopaedics Jun 2022 - Jan 2024Austin, Texas, UsHead of Regulatory Affairs and Quality Assurance and acting lead for Clinical Affairs for an orthopedic surgical applications company developing a novel robotic and software driven surgical system to usher in major advancements in major joint replacement. Accountable and reporting to CEO and CTO.Responsible for FDA registration and direct communication with Agency representatives. Responsible for regulatory strategy and Pre-Submission process to ensure RA and QA planning and content align with Agency expectations for 510k submission content for the company's first-to-market system. Responsible for writing and submitting 510k package via eSTAR/ESG. Strong RA knowledge and experience with EU/Canada/Korea/India/ROW for ongoing and dynamic considerations of possible parallel international submission paths alongside FDA 510k clearance.Responsible for developing and maintaining a new QMS system for a startup company while also investigating and implementing an eQMS solution to leverage limited resources while achieving highest compliance. Subject Matter Expert on Design Controls, Risk Management, Supplier Management, and Design and Development structured processes and gates.Also responsible for Director level role over Operations and IT/Security/Office Management. Responsible for implementation of Oracle NetSuite as the MRP system, including planning major interfaces with contract manufacturing and other major vendors ERP systems for complete manufacturing visibility. -
Site Head Of Quality - Director, Quality AssuranceCantel, A Steris Company Jun 2021 - Jun 2022Plymouth, Mn, UsSite Quality Head for Steris Endoscopy (upon acquisition of Cantel Medical) - Conroe Operations for all quality assurance and quality control functions supporting the medical division and products. Particular emphasis on single use EO sterilized disposables for endoscopic procedures. -
Site Head Of Quality - Director, Quality AssuranceCantel, A Steris Company Sep 2019 - Jun 2022Plymouth, Mn, UsPurchased by STERIS Inc June 2021 - see aboveQuality Executive for Cantel Medical - Conroe Operations for all quality assurance and quality control functions supporting the medical, dental and life sciences divisions and products.
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Sr Manager, Global Supplier Quality Engineering - NeuromodulationLivanova May 2018 - Sep 2019London, Gb -
Sr. Manager, Quality EngineeringSmith & Nephew Aug 2017 - May 2018Watford, Hertfordshire, Gb -
Sr Manager Quality - Risk ManagementBeckman Coulter Oct 2016 - Aug 2017Brea, California, Us -
Sr. Staff Design Quality Assurance EngineerBeckman Coulter Mar 2016 - Oct 2016Brea, California, Us
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Voting Delegate - Us Standards Development And AdoptionAnsi Asc Z1 Committee Apr 2016 - Dec 2016Selected as a Voting Member/Delegate representing US industry on the ANSI American Standards Committee Z1 panel charged with review, modification (if necessary) and adoption of International Standards as American National Standards.
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Voting Delegate - Us Standards Development And AdoptionU.S. Technical Advisory Group To Iso/Pc 302 Apr 2016 - Nov 2016Selected as a voting member/delegate from US industry to participate in the review and update of ISO International Standards. ISO/PC 302 is responsible for guidelines for auditing Quality Management Systems and ISO 19011.
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Quality And Regulatory Executive ConsultantValidant Mar 2015 - Mar 2016San Francisco, Ca, UsResponsible for planning and executing FDA QSIT style gap assessment, simulated audit, and consultation for corrective actions for international IVDD client and Immunology system.Responsible as a subject matter expert and team lead to deliver valued information to highly satisfied clients in the In Vitro Diagnostics and Medical Devices businesses. Responsible on recent project for team leadership and SME role in QMS and manufacturing process software/computer system validations (IQ/OQ/PQ/TMV, CSV), including interpretation of quality and regulatory requirements. Also responsible for application of external standards, guidance and regulation for development/updates/maintenance of related internal SOPs and Work Instructions. Responsible for CAPA remediation and defensible audit preparation for QMS procedures and validation master planning and overall validation status oversight for nearly 200 software based processes and systems across entire company site. -
Quality And Regulatory Engineer/ConsultantMaetrics Nov 2014 - Mar 2015Monroeville, Pa, UsResponsible as the Medical Writer for producing clinical evaluation reports (CERs) to support Class IIb implantable CE Marked medical devices in the Orthopedic device space. Review of all state of the art and applicable literature for products and comparable devices. Review and discussion of device clinical, technical, and biologic characteristics. Review and discussion of Post Market Surveillance data, CAPA's, nonconforming product trends, complaint trends, and adverse events/MDR's/Vigilance reports. -
Head Of Quality - Director Of Quality And Acting Director Of RaCardiacassist, Inc. May 2012 - Nov 2014Responsible as Head of Quality for total quality management system activities and compliance with FDA, EU, Health Canada and other international/regional regulations, standards, and guidance for mechanical cardiopulmonary and circulatory support devices. Responsible for regulatory submissions, product registrations, and compliance for the EU, LatAm, EMEA, and AsiaPac. Products include sterile disposables, mechanical hardware, as well as electromechanical and software driven devices. Responsible for design control and risk management guidance and oversight for new product development activities.
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Head Of Quality - Quality ManagerIntervala, Llc Nov 2010 - Feb 2012Greater Pittsburgh, Pennsylvania, UsResponsible for managing the Quality Department including all QA and QC functions, with a total staff of 23. ISO Management Representative for the facility.Company name changes: LaBarge > Ducommun Labarge Tech > IntervalaProducts include: -Single- and double-sided printed circuit assemblies using fine pitch, 0201, BGA and µBGA-Fully automated surface mount and through-hole assemblyBox-build electronic assemblies-Multiconductor cables, ribbon cables and specialized cable assemblies-Metal machining-System integration-Repair and maintenance services -
Principal Design Quality EngineerPhilips Home Healthcare - Respironics Jun 2007 - Nov 2010Amsterdam, Noord-Holland, NlResponsible for quality engineering and leadership support of Class II, and III medical devices from initial design through transfer, including sustaining efforts. Products include home and portable ventilation systems and patient interface masks. Responsible for providing technical expertise in V&V and quality management systems for medical device development. Responsible for process validation activities for Injection Molding (Thermoplastic and LIM) and ancillary processes. Responsible for providing leadership on QSR/CMDR/ISO compliance, GMPs, regulatory issues, risk management, validation strategy, and quality systems. Responsible for participation in and oversight of design control, change control boards, and configuration management activities. Responsible for managing on-site contractors as well as outsourced QA efforts. -
Quality Assurance ManagerB. Braun Medical Jan 2006 - May 2007Bethlehem, Pa, UsResponsible for quality assurance management and support of Class II medical devices throughout the entire lifecycle. Responsible for providing technical expertise in V&V and quality management systems for development and manufacturing processes. Responsible for providing leadership on QSR/CMDR/ISO compliance, GMPs, regulatory issues, risk management, validation strategy, and quality systems. Responsible for QA oversight of R&D outsourced efforts and contractors for hardware and software development, as well as managing the QA Documentation group, including CAPA. Responsible for managing the facility calibration program to ISO 17025. Responsible for representing the company in contact with regulatory agencies. Supervised a staff of 3 Engineers, 4 Technicians, 4 Clerks, 1 CAPA Clerk and managed a yearly budget of ~ $1,000,000. -
Senior Software And Lead Test EngineerSt. Jude Medical Aug 2000 - Oct 2005St. Paul, Minnesota, UsResponsible for V&V of software and hardware requirements for Class III medical devices. Responsible as the Project Verification Lead for test related project management activities. Responsible for technical supervision, mentoring, and training of 11 junior engineers, 4 senior engineers, and 6 contract employees. Responsible as a Lead Engineer for the technical supervision of 5 junior engineers. On an individual level, responsible for creating and maintaining test plans, including verification traceability to requirement documents. Responsible for test input to GCP and GLP studies, as well as troubleshooting support. Responsible for creating and optimizing automated and manual test procedures, as well as troubleshooting hardware and software problems. Responsible for management of automated test libraries and hardware configurations. Responsible for defect reporting, tracking, and resolution. Responsible for QSR/CMDR/MDD/ISO compliance related to verification and validation. -
Systems Engineer, Mts IiiBoeing May 1997 - Aug 2000Arlington, Va, UsResponsible (as part of a 2-man team) for the project and technical management of a key milestone test in the Delta IV Evolved Expendable Launch System and RS-68 development program. Timely and technically adequate execution of this test (at Stennis Space Center) was the sole criteria for contract award of a $66 Million milestone payment. Project responsibilities included Cost and Schedule performance management and reporting for a combined budget of over $15 Million. Technical responsibilities included requirements and specification development for a $3 Million vehicle test facility for the Delta IV First Stage. They also included large scale integration and interface definition of the Delta IV First Stage flight vehicle avionics and ground control equipment with facility command, control, and data acquisition equipment. -
Armament Engineer, Gs-12United States Department Of The Air Force Nov 1992 - May 1997Washington, D.C., UsPlanned, conducted, evaluated, analyzed and reported on USAF aircraft and weapon systems software upgrade and development test programs. Provided software and hardware test expertise in Air-Air and Air-Ground roles for fighter aircraft, and Air-Ground roles for Bomber aircraft. Experience with tactical and strategic nuclear air-ground missiles, AIM-120 (AMRAAM) air-air missiles, air-ground bomb delivery accuracy, and nuclear weapondevelopment. Also responsible for integration testing of other Armament/Avionic systems and roles such as A-G Strafe, AIM-9, A-A Gunnery, A-G Rockets. Responsible for coordinating mission support, pre-flight checkout, and conducting or monitoring real time operations for ground and flight tests. -
Liquid Rocket Engine Design Analyst, Gs-12United States Department Of The Air Force Jan 1992 - Nov 1992Washington, D.C., UsSupported system and component performance analysis of the Space Transportation Main Engine (STME) for the National Launch System program. Developed and documented robust liquid rocket engine design software in the areas of system and component performance. Applied total quality management skills as part of continuous improvement programs supporting administrative and technical duties.
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Armament Engineer, Gs-12United States Department Of The Air Force Feb 1990 - Jan 1992Washington, D.C., UsPlanned, conducted, evaluated, analyzed and reported on SRAM II separation tests as Lead B-1B Armament Engineer. Resolved mechanical and aeronautical problems relating to physical integration and launch of the SRAM II missile from the B-1B and F-15 aircraft. Maintained and modified aeronautical simulation software model used to predict SRAM-II motion during un-powered ejection from weapons bay and transition to controlled powered flight. Planned and implemented new data acquisition and data reduction techniques.
Kevin Posey, Rac Rcc Mba Cmq/Oe Skills
Songwriting
Singing
Microsoft Office
Writing
Photoshop
Rapper
Bilingual
Composition
Creative Writing
Editing
Entertainment
Event Planning
Music
Music Production
Public Speaking
Social Media
Audio Engineering
Songs
Studio Recording
Quality System
Quality Assurance
Iso 13485
Quality Management
Fda
Medical Devices
Six Sigma
Capa
Process Improvement
Quality Auditing
Manufacturing
Design Control
Validation
Root Cause Analysis
Testing
Continuous Improvement
Iso
V&v
Cross Functional Team Leadership
Quality Control
Management
Lean Manufacturing
Design Of Experiments
Product Development
Iso 14971
Dmaic
Supplier Quality
Statistics
Biomedical Engineering
Iso 9000
Engineering
Gmp
Plastics
Injection Molding
Auditing
Spc
Project Management
Process Validation
Regulatory Submissions
510 K
Ce Marking
Pma
Risk Management
Cgmp
Ide
Change Management
Medical Device R&d
Qsr
Quality Engineering
Kevin Posey, Rac Rcc Mba Cmq/Oe Education Details
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Penn State University, Graduate School Of BusinessInternational Business Management -
Pennsylvania State University-Erie CampusPlastics Injection Molding Engineering Seminars
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California Polytechnic State University-San Luis ObispoBiomedical Engineering
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University Of Southern CaliforniaSystems Engineering
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The University Of Texas At AustinAerospace Engineering
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Lanier High SchoolCollege/University Preparatory And Advanced High School/Secondary Diploma Program
Frequently Asked Questions about Kevin Posey, Rac Rcc Mba Cmq/Oe
What company does Kevin Posey, Rac Rcc Mba Cmq/Oe work for?
Kevin Posey, Rac Rcc Mba Cmq/Oe works for Genesys Spine
What is Kevin Posey, Rac Rcc Mba Cmq/Oe's role at the current company?
Kevin Posey, Rac Rcc Mba Cmq/Oe's current role is Regulatory Affairs and Quality Assurance Executive Leader | MDR PRRC | Due Diligence for Medtech M&A.
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What schools did Kevin Posey, Rac Rcc Mba Cmq/Oe attend?
Kevin Posey, Rac Rcc Mba Cmq/Oe attended Penn State University, Graduate School Of Business, Pennsylvania State University-Erie Campus, California Polytechnic State University-San Luis Obispo, University Of Southern California, The University Of Texas At Austin, Lanier High School.
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Kevin Posey, Rac Rcc Mba Cmq/Oe has interest in Technical Diving, Scuba Diving Instruction, Dive Rescue, Scuba Diving, Wreck Diving, Hyperbaric Chamber Volunteer (Past), Search And Rescue.
What skills is Kevin Posey, Rac Rcc Mba Cmq/Oe known for?
Kevin Posey, Rac Rcc Mba Cmq/Oe has skills like Songwriting, Singing, Microsoft Office, Writing, Photoshop, Rapper, Bilingual, Composition, Creative Writing, Editing, Entertainment, Event Planning.
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