Quality Assurance Regulatory Affairs
Resume:
Ralph Everett Buster, Jr.
**** ******* ***. ** • Canton, Ohio 44718
Regulatory Affairs/Quality Assurance/Compliance Professional
Driven, innovative and hands-on Regulatory Affairs/Quality Assurance/Quality Compliance executive with a 30+ year proven track record of Business Management, Operations, Regulatory Affairs and Quality Assurance. Credited with successfully building and implementing reliable and defendable quality systems meeting US (FDA) and international (i.e. ISO/MDSAP/MDR, USMDR, Health Canada, KFDA, JPAL, etc.) regulations and standards, creating and implementing system enhancements and contingency plans and resolving issues in initial stages. Strong knowledge and working history of FDA and International Regulations (including as well as building defendable Quality Management Systems. Proficient with various software packages/systems including Microsoft Office, Excel, Trackwise and Windchill.
Professional Experience
Zimmer Biomet Surgical Division – Dover, Ohio (03/2013 to present)
Sr. Director Regulatory Affairs / Quality Assurance
Responsibilities include oversight and management of Sustaining Regulatory Affairs – Internal/external audits (FDA, ISO, UL, etc.), product/facility registrations (US and international), technical files, label design, integration activities, New Product Introduction Regulatory Affairs - NPI regulatory affairs, control of quality records, recalls, field actions, quality holds, Quality Systems – CAPA system, document control, management review, metrics reporting, quality systems management, Risk – creation/maintenance of risk files, microbiology lab, HHE (Health Hazard Evaluations), Quality Assurance (4 locations) – quality engineering, quality inspection, calibration, process validation engineering, project management, Supplier Quality – supplier approvals, product transfers, NPI quality assurance. Additional responsibilities include oversight of QA/RA segments of due diligence activities (5 facilities purchased during tenure with the organization). Proficient in remediation and integration of Quality Systems, Design Transfer.
The Hygenic Corporation – Akron, Ohio (10/2001 to 03/2013)
Vice President Corporate Compliance
Responsibilities included oversight and management of RA/QA, document control, EHS, legal (product liability), IP (patents, trademarks, copyrights), facility and product registrations (65 countries outside the US) for 3 manufacturing facilities (2 – US, 1 – Malaysia). Products included OTCs, Cosmetics and Medical Devices (Class I and II). Led various corporate initiatives with multiple government agencies including FDA, OSHA, EPA, US Customs and Border Patrol. Accomplishments included leading consolidation of multiple facilities into single location, implementation of facility-wide SPC, implementation of electronic document control system meeting 21 CFR Part 11 requirements.
Pioneer National Latex – Ashland Ohio (03/2000 – 10/2001)
Technical/Quality Director
Responsibilities included management and oversight of all technical, research/design and quality organizations for a 2 facility latex/plastics company supporting a 250 employee workforce. Accomplishments included: implementation and maintenance of ISO system, complete restructuring of technical and quality organizations, documented annual cost savings of $2 million.
C.R. Bard, Inc. – Moncks Corner, South Carolina (07/1996 – 02/2000)
Production and Process Control Manager
Responsibilities included oversight and management of all production and process control functions supporting a 450 employee medical device (urinary catheter – synthetic/natural latex – Class II medical device) facility. Processes included compounding, manufacturing, packaging and distribution. Accomplishments included total restructuring of Production and Process Control departments, documented reduction of facility’s scrap by 5%, management of 2 new product lines to include design, prototyping, scale-up and manufacturing.
Additional Previous Work Experience Available Upon Request
Educational Background
Bachelor of Science, Chemistry/Biology
Liberty University - Lynchburg, Virginia
Master of Education
University of Akron - Akron, Ohio
Professional Associations / Memberships
AAMI (Association for the Advancement of Medical Instrumentation)
Member since 2006
RAPS (Regulatory Affairs Professionals Society)
Member since 2006
ASQ (American Society for Quality)
Member since 2001
ACS (American Chemical Society)
Member since 1992
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