Kevin Posey, Rac Rcc Mba Cmq/Oe Email & Phone Number

Austin, Texas, Us

Rockville, Md, Us

Professional 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).

Rockville, Md, Us

Course 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

Milwaukee, Wi, Us

Audit 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

Austin, Texas, Us

Head 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.

Plymouth, Mn, Us

Site 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.

Plymouth, Mn, Us

Purchased 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.

London, Gb

Watford, Hertfordshire, Gb

Brea, California, Us

Brea, California, Us

Selected 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.

Selected 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.

San Francisco, Ca, Us

Responsible 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.

Monroeville, Pa, Us

Responsible 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.

Responsible 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.

Greater Pittsburgh, Pennsylvania, Us

Responsible 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

Amsterdam, Noord-Holland, Nl

Responsible 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.

Bethlehem, Pa, Us

Responsible 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.

St. Paul, Minnesota, Us

Responsible 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.

Arlington, Va, Us

Responsible (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.

Washington, D.C., Us

Planned, 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.

Washington, D.C., Us

Supported 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.

Washington, D.C., Us

Planned, 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.

Mba, International Business Management

Plastics Injection Molding Engineering Seminars

Ms, Biomedical Engineering

Ms, Systems Engineering

Bachelors Of Science, Aerospace Engineering

Hs Diploma, College/University Preparatory And Advanced High School/Secondary Diploma Program