Steve White

Steve White Email and Phone Number

Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax @
Steve White's Location
West Palm Beach, Florida, United States, United States
Steve White's Contact Details

Steve White phone numbers

About Steve White

Medical Device/Combination Product Consultant designing and implementing Globally compliant Design Controls, Risk Management and Quality Management Systems. Collaborative approach and hands on expertise in working with international teams.Aided many clients in successful resolution of 483 warning letters, consent decrees, and remediation & corrections to Design Controls, Design History Files, Risk Management Files, Usability Engineering File and Technical Files.Specialties: >EU MDR STeD File conversion and conformance to EU MDR 745/746>Quality Systems and Regulatory Compliance: 483 and Consent Decree response programs>Design Controls, Risk Management implementation and integration across all QMS. >Program Management; R&D, NPD, QSR and EU MDR Remediation Planning and Implementation>Team Leadership; Cross-functional Dynamics and Mentoring>Regulatory Compliance; ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 4, EU MDR 2017/745, various IEC/ASTM industry standards

Steve White's Current Company Details
Expert Medical Device Consulting, Inc.

Expert Medical Device Consulting, Inc.

Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax
Steve White Work Experience Details
  • Expert Medical Device Consulting, Inc.
    President
    Expert Medical Device Consulting, Inc. Apr 2012 - Present
  • Expert Medical Device Consulting, Inc.
    Principal Consultant
    Expert Medical Device Consulting, Inc. Oct 2021 - May 2022
    Led the Risk Management File Review and Assessment for on-market Combination Products. Reported gaps in compliance to ISO 14971 and made recommendations for QMS improvements and remediation of Risk File documents.
  • Amgen
    Risk Files And Qms Assessment Lead
    Amgen Oct 2021 - Dec 2021
    Thousand Oaks, Ca, Us
    View
  • Pfizer
    Sme Ddqe For Dhf Remediation
    Pfizer Jun 2020 - Dec 2021
    New York, New York, Us
    View
  • Validant Consulting
    Eu Mdr Sted Lead
    Validant Consulting Jun 2018 - Jun 2020
  • Terumo Cardiovascular Systems
    Subject Matter Expert
    Terumo Cardiovascular Systems Jun 2014 - Feb 2015
    Ann Arbor, Michigan, Us
    Aided Company in meeting challenging Regulatory and Quality System Goals as Subject Matter Expert. Provided SME leadership to Process/Risk Management remediation teams and supported Test Method Validations.
    View
  • Hospira
    Subject Matter Expert And Lead For Design Transfer
    Hospira Feb 2013 - May 2014
    Providing SME expertise and co-leadership to internal team to remediate gaps and develop procedures to implement best practices for Design Transfer, Process Validation, Test Method Validation and Service Processes to meet global regulatory compliance.
  • Terumo Cardiovascular Systems
    Sme-Design Controls And Product Realization Consultant
    Terumo Cardiovascular Systems Jan 2011 - Jan 2013
    Ann Arbor, Michigan, Us
    Developing and implementing quality systems and best practices for product realization and design controls in the division's product development and service organizations.
    View
  • Heartware Inc
    Director Advanced Product Development
    Heartware Inc Jul 2006 - Aug 2009
    Framingham, Massachusetts, Us
    Developed Quality Management Systems, Agile PLM and Surgical Systems for LVAD implants
    View
  • Biomet 3I
    Director New Product Development
    Biomet 3I 2001 - 2005
    Implemented Design Controls and Risk Management Quality systems. Led the Product Development organization for innovative dental implant and restoration product(s) implementation.

Steve White Skills

Quality Systems R&d Product Development Capa Iso 13485 Iso 14971 Cgmp Practices Iec 60601 21 Cfr Part 820 Project Management Consent Decree Standards Compliance Quality System Design Controls Design Inputs Design Outputs Design Verification Design Validation Design Transfer Design Review Post Market Surveillence Iec 62366 Human Factors Engineering Use Case Analysis Requirements Traceability 21 Cfr Part 820.30 483 Warning Letter Remediation Problem Solving Qms Training Medical Devices Qms Gap Assessments And Audits Medical Devices Design Control 21 Cfr Fda Cross Functional Team Leadership Design Of Experiments Commercialization Engineering Process Improvement V&v Validation Fmea Start Ups Program Management Biomedical Engineering Product Launch Manufacturing Quality Assurance Technology Transfer Gmp

Steve White Education Details

  • Auburn University
    Auburn University
    Chemical Engineering
  • The University Of Dallas
    The University Of Dallas
    International Business
  • The University Of Dallas
    The University Of Dallas
    International Business
  • The University Of Dallas
    The University Of Dallas
    International Business

Frequently Asked Questions about Steve White

What company does Steve White work for?

Steve White works for Expert Medical Device Consulting, Inc.

What is Steve White's role at the current company?

Steve White's current role is Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax.

What is Steve White's email address?

Steve White's email address is sa****@****aol.com

What is Steve White's direct phone number?

Steve White's direct phone number is +156179*****

What schools did Steve White attend?

Steve White attended Auburn University, The University Of Dallas, The University Of Dallas, The University Of Dallas.

What are some of Steve White's interests?

Steve White has interest in Aerobics, Exercise, Home Improvement, Reading, Gourmet Cooking, Sports, Fishing, Home Decoration, Cooking, Electronics.

What skills is Steve White known for?

Steve White has skills like Quality Systems, R&d, Product Development, Capa, Iso 13485, Iso 14971, Cgmp Practices, Iec 60601, 21 Cfr Part 820, Project Management, Consent Decree, Standards Compliance.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.