Tim White
Regulatory Affairs Manager at Centrix Inc.- Claim this Profile
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Bio
Jon Angel
Tim and I worked together within the medical and dental market arena. He routinely demonstrated his ability to effectively present appropriate and critical information while clearly defining our quality and compliance requirements. The interaction with Tim in both professional and personal settings was always enjoyable. Tim will make an exceptional addition to any organization.
LinkedIn User
Tim is highly professional and great to work with. He is target oriented, reliable and has a problem-solver mindset. Tim Would be an asset to any company. He has my highest recommendation.
Jon Angel
Tim and I worked together within the medical and dental market arena. He routinely demonstrated his ability to effectively present appropriate and critical information while clearly defining our quality and compliance requirements. The interaction with Tim in both professional and personal settings was always enjoyable. Tim will make an exceptional addition to any organization.
LinkedIn User
Tim is highly professional and great to work with. He is target oriented, reliable and has a problem-solver mindset. Tim Would be an asset to any company. He has my highest recommendation.
Jon Angel
Tim and I worked together within the medical and dental market arena. He routinely demonstrated his ability to effectively present appropriate and critical information while clearly defining our quality and compliance requirements. The interaction with Tim in both professional and personal settings was always enjoyable. Tim will make an exceptional addition to any organization.
LinkedIn User
Tim is highly professional and great to work with. He is target oriented, reliable and has a problem-solver mindset. Tim Would be an asset to any company. He has my highest recommendation.
Jon Angel
Tim and I worked together within the medical and dental market arena. He routinely demonstrated his ability to effectively present appropriate and critical information while clearly defining our quality and compliance requirements. The interaction with Tim in both professional and personal settings was always enjoyable. Tim will make an exceptional addition to any organization.
LinkedIn User
Tim is highly professional and great to work with. He is target oriented, reliable and has a problem-solver mindset. Tim Would be an asset to any company. He has my highest recommendation.
Credentials
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Six Sigma Green Belt (CSSGB)
ASQ - World HeadquartersJun, 2016- Nov, 2024 -
RAPS Member
Regulatory Affairs Certification ProgramJan, 2011- Nov, 2024
Experience
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Centrix Inc.
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United States
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Medical Device
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1 - 100 Employee
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Regulatory Affairs Manager
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Aug 2022 - Present
EU MDR, FDA, regulatory affairs compliance; ISO 13485, MDSAP, ISO 14971 EU MDR, FDA, regulatory affairs compliance; ISO 13485, MDSAP, ISO 14971
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Viant Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Senior Quality Manager
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May 2019 - May 2022
Managed a Quality Department of 22, FDA QSR/GMP compliance and Inspection, and certification to ISO 13485, at a state-of-the-art, Class II medical device, contract manufacturer (includes Class 8 Clean Room, sterilization, Swiss machining) Managed a Quality Department of 22, FDA QSR/GMP compliance and Inspection, and certification to ISO 13485, at a state-of-the-art, Class II medical device, contract manufacturer (includes Class 8 Clean Room, sterilization, Swiss machining)
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Abrasive Technology, LLC
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United States
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Machinery Manufacturing
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100 - 200 Employee
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Medical Device Quality Assurance & Regulatory Affairs Management
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Jul 1999 - May 2019
Medical device compliance/certification, including ISO 13485, MDD, FDA, CMDR, MDSAP, PAL, Medical device regulatory affairs (RA), ISO 9001, AS9100 aerospace certification; quality system design, implementation, and maintenance Leadership, Quality Management, Quality Engineering, CFR Part 820, 807, 806, 801, Global Medical Device Registration, Management Rep/Correspondent, Lean, Six Sigma, Root Cause Analysis, Corrective Action (CA), Process Improvement, Auditing, Supplier Quality, Quality Training, Risk Management/ISO 14971, Process Validation, Project Management, Mistake-Proofing, MDET, DOE, Statistics, FDA Certificate to Foreign Government/CECATS, EU Technical Files (STeD), Essential Requirements, Clinical Evaluation, Risk Analysis, Usability Engineering, Declaration of Conformity Show less
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Carlisle FoodService Products
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United States
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Plastics Manufacturing
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100 - 200 Employee
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Manufacturing Manager
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Mar 1998 - Jul 1999
Managed a $3.4 million ceramic dinnerware manufacturing budget, including seven managers and 66 hourly personnel Achieved the highest monthly quality rate of 94% at a three-year old, high-volume production facility, that had typical yields of 40-50% Achieved the highest monthly productivity rate by 26% Implemented written operating procedures, incoming material quality control, and proactive quality checks of critical parameters throughout the manufacturing process Managed a $3.4 million ceramic dinnerware manufacturing budget, including seven managers and 66 hourly personnel Achieved the highest monthly quality rate of 94% at a three-year old, high-volume production facility, that had typical yields of 40-50% Achieved the highest monthly productivity rate by 26% Implemented written operating procedures, incoming material quality control, and proactive quality checks of critical parameters throughout the manufacturing process
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Technical Manager
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Sep 1996 - Mar 1998
Managed the quality and technical functions of a refractory manufacturer, including three personnel and a $200,000 budget Reduced the annual scrap rate eight percent by coordinating the ISO 9001 quality system, establishing quality goals, performing quality audits, and implementing team problem-solving within all levels of the company Audited suppliers to improve quality Established department measurements to evaluate progress towards strategic objectives Managed the quality and technical functions of a refractory manufacturer, including three personnel and a $200,000 budget Reduced the annual scrap rate eight percent by coordinating the ISO 9001 quality system, establishing quality goals, performing quality audits, and implementing team problem-solving within all levels of the company Audited suppliers to improve quality Established department measurements to evaluate progress towards strategic objectives
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Ferro Corporation
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United States
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Chemical Manufacturing
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700 & Above Employee
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Ceramic Engineer
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Nov 1990 - Sep 1996
Reduced the scrap rate of a refractory manufacturing facility by 40% or $150k/year, by using root cause problem-solving, designed experiments, and other quality tools Achieved ISO 9001 certification, performed internal quality audits, and authored quality procedures Reduced the scrap rate of a refractory manufacturing facility by 40% or $150k/year, by using root cause problem-solving, designed experiments, and other quality tools Achieved ISO 9001 certification, performed internal quality audits, and authored quality procedures
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Texas Instruments
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United States
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Semiconductor Manufacturing
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700 & Above Employee
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Design Engineer
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1988 - 1990
Managed the development of sensor components for the automotive and aerospace industries; Successfully managed a surge controller from initial design to the first working prototype – patent co-holder; Presented and justified monthly design progress to engineering and marketing management Managed the development of sensor components for the automotive and aerospace industries; Successfully managed a surge controller from initial design to the first working prototype – patent co-holder; Presented and justified monthly design progress to engineering and marketing management
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Education
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1994 - 1996
The Ohio State University - The Max M. Fisher College of Business
MBA -
1981 - 1985
Alfred University
B.S.., Ceramic Engineering
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