Tim Krotchko Email and Phone Number
Tim Krotchko work email
- Valid
- Valid
Tim Krotchko personal email
With over 13 years of experience in the medical device industry, I am the Director of Quality & Regulatory Affairs at MYCO Medical, a leading provider of innovative surgical and wound closure products. I am responsible for ensuring the quality and compliance of our products across multiple foreign government regulatory agencies, ISO, and US FDA, as well as managing and developing our global suppliers.As an ISO 13485 Lead Auditor, a Six Sigma Green Belt, and a Corporate Trainer, I have successfully implemented and maintained an FDA compliant quality system, while improving product quality, efficiency, and customer satisfaction. I am also the Management Representative to the FDA and a member of the Executive Management Team, where I offer strategic solutions and guidance to meet the evolving business and regulatory needs. I am passionate about delivering high-quality products and services to our customers, while ensuring the safety and efficacy of our medical devices.
Myco Medical
View- Website:
- mycomedical.com
- Employees:
- 19
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Director Of Quality & Regulatory AffairsMyco Medical Jul 2021 - PresentApex, North Carolina, United States
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Manager Of Regulatory Affairs & Quality AssuranceMyco Medical Feb 2013 - Jul 2021Cary, North CarolinaImplementation of an FDA compliant Quality system, while working to maintain and improve product quality through an aggressive supplier development and management program. Responsible for leading the Quality activities at the firm, my team manages Quality compliance through multiple foreign government regulatory agencies, ISO, and US FDA Good Manufacturing Practices as mandated in title 21 of the Federal Food, Drug, and Cosmetic Act.
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Quality ManagerMyco Medical Sep 2010 - Feb 2013Cary, NcI was tasked with the implementation of a working Quality System compliant with USFDA regulations for the import and distribution of Class I and Class II medical devices. Serving on the company's Management Team, I was the appointed Management Representative as defined in 21CFR820.20 and continue to serve the company in this capacity.
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Corrective Action Team MemberDaimler, Ag (Dtna) Jul 1996 - May 2009Cleveland, NcQuality Engineering - Lead information technician for Quality and Plant dashboard, assigned to lead process improvement initiatives in the Paint/Coatings unit.Certified ISO 9001/14000 Internal AuditorCertified Corporate Trainer through Learning Point, Inc.Six Sigma Green Belt trained
Tim Krotchko Skills
Tim Krotchko Education Details
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Bachelor Of Creative Arts -
Rowan Cabarrus Community CollegeAssociates In Applied Science Degree Program
Frequently Asked Questions about Tim Krotchko
What company does Tim Krotchko work for?
Tim Krotchko works for Myco Medical
What is Tim Krotchko's role at the current company?
Tim Krotchko's current role is Director of Quality & Regulatory Affairs @ MYCO Medical | Quality Management.
What is Tim Krotchko's email address?
Tim Krotchko's email address is ti****@****.rr.com
What schools did Tim Krotchko attend?
Tim Krotchko attended University Of North Carolina At Charlotte, Rowan Cabarrus Community College.
What skills is Tim Krotchko known for?
Tim Krotchko has skills like Quality Management, Quality System, Six Sigma, Quality Auditing, Manufacturing, Root Cause Analysis, Process Improvement, Supplier Evaluation, Medical Devices, Quality Control, Iso 13485, Iso.
Who are Tim Krotchko's colleagues?
Tim Krotchko's colleagues are Geoffrey Rohrer, Tomika Hicks, Karen Decker, Kristen Arch, Rosli Abdul Rahim, Rachael Griffin, Bowie Arch.
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