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Extensive expertise in the medical device industry in the areas of regulatory, quality, and operations. Hands on contributor to help companies achieve their critical regulatory goals. Diverse leader known for ability to create successful outcomes in complex and challenging situations. Team oriented with multi-functional expertise.Specialties: Quality (FDA, MDD, ISO 9001, ISO 13485, CMDR), Supply Chain, Global Logistics, Manufacturing, Depot Repair, Order Fulfillment, Lean Manufacturing.
Medical Device Consultant - Quality And Operations
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Principal ConsultantMedical Device Consultant - Quality And OperationsAssisting executives achieve strategic goals in the areas of Quality, Operations and Materials.
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Medical Device Consultant For Nicox In Operations And QualityNicox Jan 2012 - Dec 2016San Francisco Bay AreaNicox is building an international, late-stage development and commercial Ophthalmology Company based around therapeutics, diagnostics and devices. -
Vice President, Operations And QualityCalhoun Vision, Inc. Jun 2010 - Jul 2011Member of the Calhoun Vision management team responsible for Operations and Quality. Developed and streamlined business processes. Managed key suppliers to support the growth of the organization. Interfaced with FDA and other regulatory bodies and ensure compliance with ISO 13485, MDDA and CMDA. Directed Validation and Verification activities on new product and/or software releases. -
Director Of Consulting ServicesStrategic Information Groupst Jun 2009 - May 2010As a Medical Device Consultant I provided leadership and guidance to various Medical Device Manufacturers to achieve key business objectives. Key milestones include: - Developed Master Validation Plan and Strategy to incorporate QAD Mfg Pro with the Arena System for managing product life cycles and documentation management. -Developed requirements and validation plan to implement electronic non-conformance and MDR processing for the Nueromodulation group. Reviewed current… Show more As a Medical Device Consultant I provided leadership and guidance to various Medical Device Manufacturers to achieve key business objectives. Key milestones include: - Developed Master Validation Plan and Strategy to incorporate QAD Mfg Pro with the Arena System for managing product life cycles and documentation management. -Developed requirements and validation plan to implement electronic non-conformance and MDR processing for the Nueromodulation group. Reviewed current business processes and assisted with “lean” approach to transition manual (FEDX) MDR submission to electronic MDR submission through the FDA gateway. Show less -
Medical Device ProfessionalCreekwood Consulting Oct 2007 - Jun 2009Medical Device Professional specializing in Operations, Quality and Service. Recent projects include:*Sr. Business Consultant and Project Manager, NetRM Regulatory and Quality Management Software. Providing leadership and guidance in redesigning Quality System processes, and implementing the NetRM Quality Enterprise Software.*Strategic Planning - Identifying and selecting key suppliers for start-up Med Device companies to support clinicals and NPI.*Advanced Medical Optics –… Show more Medical Device Professional specializing in Operations, Quality and Service. Recent projects include:*Sr. Business Consultant and Project Manager, NetRM Regulatory and Quality Management Software. Providing leadership and guidance in redesigning Quality System processes, and implementing the NetRM Quality Enterprise Software.*Strategic Planning - Identifying and selecting key suppliers for start-up Med Device companies to support clinicals and NPI.*Advanced Medical Optics – Project Manager. Provided leadership and guidance to insure FDA approval of new 180K facility in Milpitas. Successfully executed validation and achieved FDA registration of new facility Show less
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Vice President Of OperationsAmo May 2005 - Oct 2007As a member of Global Operations Executive Team I was responsible for Santa Clara facility which supported the growth of multiple business units, including Laser Vision Correction and Cataract. Responsible for Santa Clara Manufacturing P&L. with a department of up to 150 people with seven direct reports and annual budget of $30 Million. -
Vice President, OperationsVisx Oct 2002 - May 2005As member of the Executive Leadership Team I provided strategic vision and planning to support our mission of setting a new standard of care for LVC procedures with annual global sales and service of over $200M. Areas of responsiblity included Manufacturing, Depot Repair, Order Fulfillment, Quality, and Supply Chain.
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Frequently Asked Questions about Terrie Johnson
What company does Terrie Johnson work for?
Terrie Johnson works for Medical Device Consultant - Quality And Operations
What is Terrie Johnson's role at the current company?
Terrie Johnson's current role is Medical Devices, Quality Consultant, SME ISO 13485 and EU 2017/745, FDA Part 820.
What is Terrie Johnson's email address?
Terrie Johnson's email address is te****@****cox.com
What is Terrie Johnson's direct phone number?
Terrie Johnson's direct phone number is +183134*****
What are some of Terrie Johnson's interests?
Terrie Johnson has interest in Children, Education, Environment, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Animal Welfare, Health.
What skills is Terrie Johnson known for?
Terrie Johnson has skills like Biomedical Engineering, Quality Management, Capa, Manufacturing, Lifesciences, Quality System, Strategy, Cross Functional Team Leadership, Order Fulfillment, V&v, Enterprise Software, Start Ups.
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Terrie Johnson
It Manager Of Support Services & Project Lead At General CableKentucky, United States2generalcable.com, prysmiangroup.com3 +151390XXXXX
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Terrie Johnson
Ibm Baton Rouge Cic - North America Hybrid Cloud Manage (Hcm) Senior Delivery Lead And Practice LeaderZachary, La1ibm.com -
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