Ray G. Email & Phone Number

Cleveland, Oh, Us

Les Charbonnières, Ch

• Hold full responsibility and ownership for all aspects of 21CFR 820 / ISO 13485-2016 Quality Assurance and Regulatory Compliance and Inspection for North America. • Successfully defended & supported ISO 13485-2016 Registrar Certification / Surveillance Audit with no findings. 2022 • Registered FDA Company Representative (FURL) for 3 manufacturing sites; North America, Morocco and Switzerland (Corporate Office). Supported FDA audit as Key Manager of Front Room and Scribe duties. (April 2023). • Developed and implemented an approved OSHA Safety Program per 29 CFR 1910. Established Safety Committee as acting chairman responsible for leading the safety team, while reducing safety mishaps by creating awareness. • Established sustainable Training program for IPC 610 Certification and supporting of successful implementation of Learning Management System- LMS • Report directly to the President of Valtronic with supervisory responsibility 15 direct reports. • Developed Quality Department Quality and Regulatory and QC Inspection Team from ground up. • Drive process improvements in support of EOS/Traction principals and methodology L10 EOS. • Key Project: Completed GAP assessment of QMS, Management Review- Annual 2022 to Quarterly 2023. Reduced Scrap output by 40% (2022). Established Contingency Plan, Safety Plan and Risk Assessment. • Create Supplier Capability and Risk Assessment in evaluating and qualifying critical and approved suppliers. • Established Continual Improvement, CAPA, MRB, and Complaint Monthly meetings supporting process improvements. • Implemented and maintained the Quality Management System / Quality Dashboard to support data driven KPIs. • Key Member of Executive Leadership Team

Concord Twp., Ohio, Us

• Hold full responsibility for all aspects of ISO 9001-2015 Quality Management Systems for 4 Manufacturing sites within North America. Hold secondary responsibility for providing assistance serving as a Safety Lead in support of creating a safety minded culture. • Report directly to the Vice President of Operations with supervisory responsibility 10 direct reports. • Spearhead processes improvements driving continual improvements across plants. Developed and improved Ranpak requirements for First Article Inspections, Deviations and Inspection of parts reducing the number of non-conforming material improving first pass rate of parts to 95% (2022) and Machine Inspection 100%. (2022). • Serve as the company’s authorized designee for oversight of the Quality Management System. Project lead for Forestry Service Certification (FSC), Environmental, Social, Governance and identifying Risk(s) to Enterprise. • Implemented and/or updated Quality Management System and processes necessary to ensure compliance with current regulatory, statutory requirements and compliance. • Develop and maintain programs for of internal and external quality functions via audit programs to qualify and maintain the quality conformance of related products -finished goods, Raw Material -Incoming Inspections, Qualifying of Suppliers, Vendors, Contractors and Sourcing.• Cross-Collaboration with Process owners, Departmental Managers to improve process efficiencies by creating quality and safety awareness throughout the organization globally. • Develop Key Performance Indicator through the incorporation of Operational Dash Board that measure and monitors the Quality, Production, Safety, Environmental and Health Performance of the Organization. • Led Quality in support of SAP HANA S4 / Implementation and Transition. • Effective mediator in creating empowerment, ownership and accountability that fosters mutual respect, trust & collaboration. • Key member of the Senior Management Team.

Cleveland, Ohio, Us

-Directly responsible for implementing, maintaining and providing oversight of the company’s ISO 9001 Quality Management Systems for a Chemical manufacturing (3) sites; Additives (ELCO Corp.), MWS (Italmatch Chemicals SC, LLC) and Hydrochloric Acid / Pharmacopeia (Detrex Chemicals) products.-Lead successful FDA certification / re-certification and Auditing activities for API, USP-NF Pharmacopeia, Excipient and Food Grade FCC Hydrochloric Acid (HCL). -Certified FSPCA PCQI Lead. Experienced in the prevention, development and execution of Food Safety Plan, Team Management and Development, Hazard Analysis and Critical Control Points (HACCP) .-Lead Senior Management Team for all QMS activities for all sites and reporting quality metrics KPIs.-Responsible for ensuring document change control procedures are followed within the scope of the QMS to include retention of records.-Establish Quality objectives by collaborating with process owners, ensuring continual improvement and corporate strategies are incorporated to measure effectiveness and performance.-Lead Auditor for ISO 17025, 9001:2015, ISO 14001-2015, ISO and FSSC 22000. CQA ASQ, EHS Programs. -Conduct External Supplier Audits and Vendor Management. -Developed and executed 3 successful transition plan to ISO 9001:2015 certification and (1) ISO 14001-2015 certification.-Coordinate all CAPA investigations, Customer Complaints, Risk mitigation ensuring Corrective and Preventative measures are implemented in a timely manner. Determine Root-Cause. -Lead Quality “Call to Action” initiatives to create process ownership and accountability. -Provide training deliveries on Quality Management Systems; ISO 9001, IS0 14001, cGMP and cGDP. -Analyze data on the effectiveness of processes using core tools, (SPC) and Fishbone Analysis, 5S and 8D methodologies. -Drive change by instilling Trust, Mutual Respect and Commitment to Quality, Environment and Safety.

Oakwood Village, Ohio, Us

- Manage CHU design and ensure Complaint Handling, Device Reporting and Product Return processes are compliant with domestic and international regulations (i.e. MDD, CFR and ISO13485 and other applicable regulations, Medical Device Reporting, Vigilance Reporting, Canadian Problem Reporting and other worldwide reporting requirements). - Assist with the development and implementation strategies to support corporate quality objectives and continuous improvement goals related to customer complaints such as reduction in complaint backlog and complaint closure cycle time. - Design and coordinate worldwide complaint processing and reporting training programs for the Complaint department and other departments as required. - Design, distribute and educate the company and staff on product complaint and department performance metrics (e.g. weekly, monthly, quarterly, yearly). - Collaborate with other departments as needed and in identifying, testing, and implementing work process and system improvements. - Participate on new product design teams and create corporate strategy to launch new and sustain current products and create policies to receive product returns, investigate product complaints, process complaint documentation and report adverse events.

Lead Business development and chartering activities for growing the credit union. Develop marketing and sales strategies for geographical areas in support of Pre-Chartering requirements / package submission to NCUA. Collaborate with city advisors to align business strategies with economic development of city planning. Drive CU efficiencies, expand financial portfolio through best practices in investments, lending, collections and reduce financial / operational risk. Support needs of and expand the CU membership.

Amsterdam, Noord-Holland, Nl

Assures training programs support QS and regulatory compliance. Create and develop training strategies through the use of skill based learning and required employee knowledge. Provides guidance in training and adheres to Quality and Regulatory standards for each type of training developed through the Q&R department.

Amsterdam, Noord-Holland, Nl

Manage and provide oversight for the development and delivery for ILT training deliveries for Global Sector North America.

Amsterdam, Noord-Holland, Nl

BV Family (Surgical C-ARMs) Course Developer and Instructor for Philips Health Care.

Cleveland, Ohio, Us

Developed a compliant maintenance training department from ground up. Established training curriculum and database for over 500 personnel. Authored a Maintenance Training Manual, General Maintenance Manual, and Required Inspection Items Training Manual, Reduced Vertical Separation Minimums Training Manual and Train the Trainer Manual and an approved Maintenance Vendor Manual. Coordinated a training schedule and directly managed the roll out training for company personnel, including external personnel including vendor maintenance, 3rd party maintenance and tracked training progression matrix. Acheivements: Closely worked with the Cleveland Flight Safety District Office in ensuring maximum participation by company employee's allowing the company to recieve the prestegious FAA "Diamond Award" by CLE-FSDO for excellence in training and recurrent training and training development. 2006.

Vandalia, Oh, Us

Dba, Global Business & Leadership

Mas, Management & Safety

Bs, Professional Aeronautics