Rex A. White

Rex A. White Email and Phone Number

Medical Device and QMS Professional @ Leesburg, IN, US
Leesburg, IN, US
Rex A. White's Location
Leesburg, Indiana, United States, United States
Rex A. White's Contact Details
About Rex A. White

Experienced Medical Device Professional with a demonstrated history of working in the medical device industry. Skilled in Operations Quality Management, Medical Devices, 21 CFR, ISO 13485, 14971 and Lean Management.

Rex A. White's Current Company Details
R. A. White Quality System Consulting, LLC

R. A. White Quality System Consulting, Llc

Medical Device and QMS Professional
Leesburg, IN, US
Rex A. White Work Experience Details
  • R. A. White Quality System Consulting, Llc
    Medical Device And Qms Professional
    R. A. White Quality System Consulting, Llc
    Leesburg, In, Us
  • R. A. White Quality System Consulting, Llc
    Medical Device/Qms Professional
    R. A. White Quality System Consulting, Llc Nov 2016 - Present
    Midwest
    Regulatory compliance/quality professional in the medical device industry. Auditor for manufacturing sites, supplier audits and qualifications. Is able to review quality systems to identify gaps and strengthen the quality system into a state of compliance. Operations/quality partner that creates a comprehensive understanding of the quality system regulations.Knowledge of quality system regulations in accordance with 21 CFR Parts 11, 210, 211, 820, 1271 and ISO 13485 and 14971.
  • Zimmer Biomet
    Vp, Quality Assurance And Regulatory Compliance, Americas
    Zimmer Biomet Jun 2015 - Oct 2016
    Warsaw
    Responsible for all quality assurance activities (process and supplier quality engineering, gauge development and calibration, FAI, and continuous improvement) throughout the Americas and Puerto Rico facilities. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, PMS generation, complaint handling, CAPA system, and quality system management). Responsible for quality planning (product and process planning).Facilitate 3rd party (FDA, Notified Bodies) quality system, process, and product audits. Special processes and software validation studies, i.e., protocols, reporting, and summaries are performed as needed. Oversees the corrective and preventive actions (CAPA) program and maintains database. Maintains open communication with all departments. Maintains annual budget and communicates company and departmental objectives to subordinates. Administers company policies (corporate best practice).
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  • Biomet
    Vp, Regulatory Compliance / Quality Assurance, Biomet Operations
    Biomet Sep 2010 - Jun 2015
    Warsaw
    Management Representative at the Warsaw facility. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, complaint handling, CAPA system, and quality system management). Responsible for all quality assurance activities (design, process, and supplier quality engineering, gauge development and calibration, inspection criteria development, FAI, and continuous improvement). QA/RC reporting responsibilities at Biomet sites in Warsaw, In, Fair Lawn, NJ, Miami, FL, Irvine, CA, and two facilities in China.
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  • Biomet Orthopedics
    Vp, Regulatory Compliance / Quality Assurance
    Biomet Orthopedics Jan 2007 - Sep 2010
    Warsaw, In
    Management Representative at the Warsaw facility. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, PMS generation, complaint handling, CAPA system, and quality system management). Responsible for all quality assurance activities (design, process, and supplier quality engineering, gauge development and calibration, inspection criteria development, FAI, and continuous improvement).
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  • Biomet
    Director, Regulatory Compliance
    Biomet Jan 2003 - Jan 2007
    Warsaw, In
    • Responsible for the regulatory compliance department at the Warsaw and Fair Lawn facilities.• Scheduling of quality system, process, and product audits.• FDA investigations and BSI assessments are performed as required.• Special processes requiring validation studies, i.e., protocols, reporting, and summaries are performed as needed.• Oversees the corrective and preventive actions (CAPA) program and maintains database.• Maintains open communication with all departments.• Maintains annual budget and communicates company and departmental objectives to subordinates.• Management Representative at the Warsaw, IN and Fair Lawn, NJ facilities. • Administers company policies.
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  • Biomet
    Director, Quality Assurance
    Biomet Dec 1996 - Jan 2003
    Warsaw, In
    View
  • Biomet
    Manager, Quality Assurance
    Biomet Dec 1991 - Dec 1996
    Warsaw, In
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  • Biomet
    Quality Assurance Engineer
    Biomet Nov 1990 - Dec 1991
    Warsaw, In
    • Responsible for quality engineering within the knee team, which was the first integrated work team.• Establishes and maintains criterion for projects.• Designs gauging for shop floor applications and trains team members on their usage.• Implements corrective and preventive actions based on deviation trend analysis reports.• Supervises the Metrology Laboratory and departmental quality clerks.
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  • Depuy Orthopaedics
    Quality Control Supervisor
    Depuy Orthopaedics Oct 1975 - Nov 1990
    Warsaw, In

Rex A. White Skills

Quality Assurance Quality Management Quality System Quality Auditing Iso 13485 21 Cfr Part 11 21 Cfr Part 820 Regulatory Requirements Operations Management Lean Manufacturing Lean Management Cleaning Validation Validation Special Process Validation Risk Management Calibration Capa Orthopedic Change Management Supplier Quality Metrology Manufacturing Medical Devices Iso Root Cause Analysis Continuous Improvement Cross Functional Team Leadership Spc 21 Cfr 5s U.s. Food And Drug Administration Design Control Fda Corrective And Preventive Action Orthopedics Iso Standards Gmp Statistical Process Control Quality Control Verification And Validation Surgical Instruments

Rex A. White Education Details

Frequently Asked Questions about Rex A. White

What company does Rex A. White work for?

Rex A. White works for R. A. White Quality System Consulting, Llc

What is Rex A. White's role at the current company?

Rex A. White's current role is Medical Device and QMS Professional.

What is Rex A. White's email address?

Rex A. White's email address is re****@****mer.com

What is Rex A. White's direct phone number?

Rex A. White's direct phone number is +133034*****

What schools did Rex A. White attend?

Rex A. White attended Goshen College, Purdue University, University Of Notre Dame - Mendoza College Of Business.

What skills is Rex A. White known for?

Rex A. White has skills like Quality Assurance, Quality Management, Quality System, Quality Auditing, Iso 13485, 21 Cfr Part 11, 21 Cfr Part 820, Regulatory Requirements, Operations Management, Lean Manufacturing, Lean Management, Cleaning Validation.

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