Tammy Gauthier work email
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Tammy Gauthier personal email
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QA professional with successful QMS oversight and implementation to support phase appropriate Investigational drug development, GMP, GCP, IND, NDA, Pre-Clinical, Clinical and Commercial phase medicinal product launch. Strong emphasis in Quality Assurance practices, Quality Management Systems and implementation. Vendor Management and Qualification of external operations, cGMP Batch record review, release and assemble Forma package to support QP CoR for Phase I/Phase II/III. Support and manage CTIS RFIs gateway and regulatory submissions (clinicaltrials.gov). Oversight of eTMF and CTMS. MS Regulatory Affairs for Drugs, Biologic's and Medical Devices
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Director Of QualityCuradel Pharma Jun 2024 - Present -
Quality ManagerCuradel Surgical Innovations Jun 2018 - Jun 2024Oversee internal and external Quality Systems, GMP, GCP, Supplier Development, and New Product Development, Regulatory Submissions. Provide guidance to consistently and effectively implement and monitor Curadel’s Quality Management System and projects to ensure the manufacture of high quality product, and facilitate compliance within regulatory landscapes and global requirements in both the US and Europe. Lead and support QP Certificate of Release operations, CTIS and ClinicalTrials.Gov submission administrator.
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Mechanical EngineerCuradel, Llc Jun 2018 - Apr 2020Early stage development activities for FlareScope product family. Design and development activities including optical housing, pathology enclosure system and handheld MiniFlare disposable system.
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Sr. Engineering Consultant @ BscEnhanced Compliance Inc. May 2017 - Apr 2018Marlborough, Massachusetts, Us@Boston Scientific. Evaluation of design history files/ technical files of acquired Neuromodulation product line consisting of various RF Electrodes used in nerve ablation to assist patients with pain management. Duties included scrubbing Design Plans, Design reviews, Design change, design inputs/design outputs, product specifications, verification, validation, marketing requirements, and risk analysis. All findings and deficiencies were documented and reviewed to assist in readiness reports. -
Mechanical Design @ Mit Lincoln LabsRandolph Associates, Inc. Jun 2016 - May 2017Cambridge, Ma, UsMechanical Engineering Support for internal and external customers. Designed enclosures for Flight, Satcom Division. Solidworks -
Mechanical EngineerDimensional Photonics International; Danaher May 2011 - Dec 2015R&D, Product development handheld intra-oral 3-D scanner. Mechanical/Opto design and develop and development activities included concept to completion, sustaining, design transfer and lead 2nd generation mechanical engineering efforts
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Mechanical Design EngineerMicroline Surgical (Aries Group) Feb 2011 - Jun 2011Beverly, Ma, UsContract Assignment Engineering Support RA & R&D -
Mechanical DesignerCornova Jun 2010 - Oct 2010UsShort Term contract assignment, Mechanical Designer R&D Medical Devices -
Mechanical DesignerGe Healthcare Apr 2006 - Mar 2010Chicago, UsSurgical navigation instrumentation, hand held device; Cranial, ENT, Spine -
Mechanical DesignerLuminus Devices 2005 - 2006Sunnyvale, Ca, Us -
Mechanical Designer "B"American Superconductor (Davis Engineering) 2004 - 2005Ayer, Massachusetts, UsEngineering and Production Support; Solidworks -
Engineering TechSeranoa Networks 2002 - 2003
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Test TechSonus Networks Jun 1998 - Jan 2002Westford, Ma, Us -
TechnicianDigital Equipment Bcfi Ab Apr 1990 - Nov 1998
Tammy Gauthier Skills
Tammy Gauthier Education Details
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Northeastern UniversityAnd Medical Devices -
Northeastern UniversityMaster Of Science - Ms
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University Of Massachusetts LowellMechanical Engineering
Frequently Asked Questions about Tammy Gauthier
What company does Tammy Gauthier work for?
Tammy Gauthier works for Curadel Pharma
What is Tammy Gauthier's role at the current company?
Tammy Gauthier's current role is Director of Quality at Curadel Pharma.
What is Tammy Gauthier's email address?
Tammy Gauthier's email address is ga****@****ail.com
What schools did Tammy Gauthier attend?
Tammy Gauthier attended Northeastern University, Northeastern University, University Of Massachusetts Lowell.
What skills is Tammy Gauthier known for?
Tammy Gauthier has skills like Medical Devices, Product Development, Solidworks, Engineering, R&d, Testing, Manufacturing, Design For Manufacturing, Mechanical Engineering, Iso 13485, Design Control, Fda.
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