Rafael Bonilla, MBA

*** **** **** ******

Lorain, OH 44052

440-***-****

acx7og@r.postjobfree.com

Quality and Regulatory professional with 20 years of progressive experience implementing and supporting processes that ensure compliance and meet or exceed quality metrics. Experienced in all phases of Quality Management Systems, including Design Controls, Corrective Actions, Management Review, Complaints, Audits, Production and Process Controls, Supplier Audits, Risk and Data Analysis as well as working experience in an ISO 13485, 9001, and FDA Quality System Regulations (21 CFR Part 820) compliant system. PROFESSIONAL EXPERIENCE

Quality & Regulatory Manager/ Engineer

ScottCare Corp, Cleveland, OH September 2010 - Present ScottCare (a Berkshire Hathaway company) provides medical devices, software, data integration and clinical support solutions to aid hospitals and cardiology practices in the diagnosis, rehabilitation and management of cardiovascular disease. Assistant and back-up to the Director of Quality & Regulatory in all functions required for continuance of the Quality Management System and company compliance with global medical device regulations.

• Assist and lead as required all Notified Body audits, including ISO 13485, CE, and CMDCAS. o Recently lead project and full successful audit for company change over to major Notified Body, yielding a year over year cost savings and shorter lead time for Technical File reviews for improved speed to market of products.

• Assist and lead as required all FDA inspections.

• Lead all unannounced National regulated testing lab audits (i.e. CSA).

• Manage the Corrective/Preventive Action program; ensure implementation of corrective actions, and follow-up effectiveness checks.

• Conduct investigations, initiating and processing actions from quality system feedback information (records review, acceptance activities, non-conforming material reports, corrective action reports, complaints, and audit reports).

• Manage the corporate Training program.

• Assist and lead as required Management Review meetings with the Executive Leadership Team.

• Participate in Post-Market Surveillance of all products including Quality Metrics tracking and reports.

• Manage Engineering Change Control Board (CCB), from inception through design transfer.

• Assist the risk management review team with risk assessments during the release of new products and revisions/improvements to existing products.

• Manage Document Control for the Quality Management System.

• Manage the Calibration program; ensure on-time calibration of all testing and measurement equipment.

• Lead the implementation of quality assurance plans and production and process controls.

• Manage the Preventive Maintenance (PM) program; monitor and ensure all PM’s are completed as scheduled.

• Participate on Material Review Board (MRB) for nonconforming material, including supplier quality. Quality/ Utility Technician

Ford Motor Company, Lorain & Avon, OH September 1999 – September 2010 Ford Motor Company is a global automotive company that together with its subsidiaries, designs, manufactures, markets, finances, and services automobiles.

• Subject matter expert, filling in for as many as 40 roles in multiple departments.

• Lead successful campaigns to ensure products leaving production facility were correct and compliant with torque specifications.

• Participated in weekly preventative maintenance programs.

• Participated in the Ford Production System implementation (FPS)

• Implemented and ensured corrective actions were addressed appropriately.

• Ensured that health and safety were addressed.

• Managed Scrap racks for ongoing trends.

• Active member on multiple teams including: Safety team, Ford Production System implementation (FPS), Local 425 Union Chaplaincy and Hispanic committees.

Assembly Associate

Ford Motor Company, Lorain, OH May 1995- September 1999 EDUCATION:

Master of Business Administration (MBA)

Indiana Wesleyan University, Marion, IN August 2012 Bachelor of Science

Moody Bible Institute, Chicago, IL May 2008

PROFESSIONAL ASSOCIATIONS:

American Society for Quality (ASQ) 2010 - Present

Regulatory Affairs Professional Society (RAPS) 2014 - Present REFERENCES:

Available upon request

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