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.

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.
• 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.
• 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.

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.

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.

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.

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.

Vandalia, OH, US

Dba, Global Business & Leadership

Mas, Management & Safety

Bs, Professional Aeronautics