Marjorie Nelson, Mba

Marjorie Nelson, Mba Email and Phone Number

Co-Founder, Chief Operating Officer at Aurie @ Aurie
Cape Canaveral, Florida, United States
Marjorie Nelson, Mba's Location
Cape Canaveral, Florida, United States, United States
Marjorie Nelson, Mba's Contact Details

Marjorie Nelson, Mba personal email

n/a
About Marjorie Nelson, Mba

Passionate and energetic leader, with 20+ years operations experience, 17 years medical device and a subset of that time in drug operations. Successful in building and leading teams in highly technical operations environments with stringent cGMP and regulatory requirements.- Product & process development of 5 innovative medical devices- Stability protocols for pharmaceutical development and registration batches- 510K and NDA submission teams, responsible for CMC writing and reviewing- Subject Matter Expert in FDA Pre-Approval Inspection (PAI) for drug applications and 501K for medical device applications- Leadership of technical transfers between facilities and CMO'sRequirements and Guidelines:21 CFR Parts 210 & 21121 CFR Parts 11 & 820ISO 9001, 19011 & 13485ICH Q1A - Q1F, Q7, Q8, Q9, Q10

Marjorie Nelson, Mba's Current Company Details
Aurie

Aurie

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Co-Founder, Chief Operating Officer at Aurie
Cape Canaveral, Florida, United States
Website:
livewithaurie.com
Employees:
16
Marjorie Nelson, Mba Work Experience Details
  • Aurie
    Aurie
    Cape Canaveral, Florida, United States
    View
  • Cook Device Solutions, Llc
    Subject Matter Expert/Contributor
    Cook Device Solutions, Llc Mar 2021 - Feb 2023
    Indianapolis, Indiana, Us
    View
  • 3Dt Holdings
    Director Of Qe/Qa
    3Dt Holdings Mar 2021 - Aug 2022
    View
  • Nelson Drug & Device Services Llc
    President
    Nelson Drug & Device Services Llc Apr 2019 - Aug 2022
    Solutions Expedited.Nelson Drug & Device can help you quickly and effectively construct a QMS, establish an internal audit plan, source and qualify contract manufacturers, prepare your business for FDA PAI/PMA, ISO, MDSAP inspections, or establish remediation plans. We bring a broad base of knowledge, experience, and internationally recognized certifications ensuring you get the skills you can trust in the timeframe that your business needs.
    View
  • 3Dt Holdings
    Director Of Quality Engineering/Assurance
    3Dt Holdings Sep 2019 - Mar 2021
  • Vero Biotech
    Vp Of Strategic Innitiatives
    Vero Biotech Nov 2018 - Apr 2019
    Atlanta, Ga, Us
    View
  • Vero Biotech
    Vp Of Technical Operations
    Vero Biotech Jan 2018 - Nov 2018
    Atlanta, Ga, Us
    View
  • Vero Biotech
    Vp Of Manufacturing
    Vero Biotech Jul 2016 - Jan 2018
    Atlanta, Ga, Us
    View
  • Vero Biotech
    Director Of Manufacturing
    Vero Biotech Oct 2014 - Jul 2016
    Atlanta, Ga, Us
    View
  • Irobot
    Program Manager, Remote Presence Operations
    Irobot Apr 2014 - Sep 2014
    Bedford, Massachusetts, Us
    View
  • Mobius Imaging, Llc
    Director Of Manufacturing
    Mobius Imaging, Llc Nov 2012 - Apr 2014
    Shirley, Ma, Us
    Member of senior staff, responsible for developing and supporting operational procedures and transitions, develop manufacturing process and team, provide input on critical business strategy, hires and initiatives. Regular interactions with notified bodies, distribution partners, physicians and surgeons.
    View
  • St. Jude Medical (Formerly Lightlab Imaging)
    Director Of Manufacturing
    St. Jude Medical (Formerly Lightlab Imaging) Aug 2004 - Nov 2012
    St. Paul, Minnesota, Us
    Develop annual operating plans and long term strategic operations. Manage annual budgets. Deliver operational quality consistent with FDA, GMP, MHLW and other certificate requirements, ensured ISO 13485 compliance, build strong cross-functional teams, and present reports to senior staff.
    View
  • Zygo Teraoptix
    Process Engineer
    Zygo Teraoptix 1999 - 2002
    Coordinate prototype projects utilizing cross-functional teams. develop new processes, fixtures, and tests for fiber optic components. Interacted with key clients / customers to develop modifications and enhancements to existing products.
  • Corning Lasertron
    Process Engineering
    Corning Lasertron 1998 - 1999
  • Mke-Quantum Components Llc (Formerly Digital Equipment Corporation)
    Wafer Fabriciation
    Mke-Quantum Components Llc (Formerly Digital Equipment Corporation) Jan 1990 - Jun 1998

Marjorie Nelson, Mba Skills

Medical Devices Iso 13485 Manufacturing Biomedical Engineering Project Management Fda Design Control Cross Functional Team Leadership Product Development R&d Quality System Six Sigma Design For Manufacturing Capa Process Engineering Validation Design Of Experiments Continuous Improvement Lean Manufacturing V&v Engineering Root Cause Analysis Manufacturing Engineering Spc Iso 14971 Fmea Semiconductors Gmp Iso Dmaic Product Launch Injection Molding Commercialization Materials Management Research And Development U.s. Food And Drug Administration

Marjorie Nelson, Mba Education Details

  • Questrom School Of Business, Boston University
    Questrom School Of Business, Boston University
    Master Of Business Administration (Mba)
  • Becker College
    Becker College
    Management Concentration
  • Northeastern University
    Northeastern University

Frequently Asked Questions about Marjorie Nelson, Mba

What company does Marjorie Nelson, Mba work for?

Marjorie Nelson, Mba works for Aurie

What is Marjorie Nelson, Mba's role at the current company?

Marjorie Nelson, Mba's current role is Co-Founder, Chief Operating Officer at Aurie.

What is Marjorie Nelson, Mba's email address?

Marjorie Nelson, Mba's email address is mn****@****bot.com

What schools did Marjorie Nelson, Mba attend?

Marjorie Nelson, Mba attended Questrom School Of Business, Boston University, Becker College, Northeastern University.

What are some of Marjorie Nelson, Mba's interests?

Marjorie Nelson, Mba has interest in Social Services.

What skills is Marjorie Nelson, Mba known for?

Marjorie Nelson, Mba has skills like Medical Devices, Iso 13485, Manufacturing, Biomedical Engineering, Project Management, Fda, Design Control, Cross Functional Team Leadership, Product Development, R&d, Quality System, Six Sigma.

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