Jolanda Oorthuizen

Quality Assurance and Regulatory Affairs Manager at LivAssured BV
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Contact Information
us****@****om
(386) 825-5501
Location
Leiden, South Holland, Netherlands, NL
Languages
  • English Professional working proficiency
Skills

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Lieke Peper

I supervised Jolanda during her research internship as part of her MSc program at the Faculty of Human Movement Sciences of the VU University Amsterdam. Jolanda was a very good student. She worked hard, took initiative, and functioned very independently. She has good computer programming skills (matlab), as well as good statistical and writing skills. I would recommend her for a PhD studentship any time

Marian Schoone

Jolanda heeft tijdens haar stage bij TNO laten blijken dat ze heel resultaat gericht werkt. Zij toonde grote inzet en was kritisch op haar eigen werk. Het lukt haar om snel thuis te raken in een onderwerp. Haar analytisch vermogen is goed en ze kan uit veel informatie de samenhang en prioriteiten halen. Jolanda is een gedreven onderzoeker met grote drang naar perfectie.

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Credentials

  • Advanced Risk Management for Medical Devices and ISO 14971:2019
    Medical Device HQ
    Sep, 2023
    - Nov, 2024
  • ISO 14971:2019 Risk Management for Medical Devices
    Medical Device HQ
    Aug, 2021
    - Nov, 2024
  • Internal Auditor ISO 13485:2016
    BSI
    Oct, 2020
    - Nov, 2024
  • Medical Devices Regulation (MDR) 2017/745 Training
    ISS AG, Integrated Scientific Services
    Mar, 2019
    - Nov, 2024
  • Management Training (communication skills)
    Foresee BV
    Sep, 2017
    - Nov, 2024
  • Customer Oriented Communication Skills
    ISA training & coaching B.V.
    Sep, 2014
    - Nov, 2024

Experience

  • LivAssured BV
    • Netherlands
    • 1 - 100 Employee
    • Quality Assurance and Regulatory Affairs Manager
      • Apr 2022 - Present

  • CAM Bioceramics B.V.
    • Netherlands
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Team Lead QA
      • Oct 2021 - Apr 2022

    • Senior Quality Assurance Specialist
      • Jul 2021 - Apr 2022

  • Motek Medical B.V.
    • Netherlands
    • Medical Device
    • 1 - 100 Employee
    • Head of Quality Management and Regulatory Affairs
      • Jun 2020 - Jul 2021

      Regional head of QMRA department for the Dutch branch of DIH, Motek Medical BV Contact person for the notified body , Management representative. Leadinternal auditor for ISO 13485:2016. In the lead of making the QMS MDR compliant.

    • Chairman of the Works Council
      • Apr 2019 - Jul 2021

    • Product lifecycle manager
      • Sep 2017 - Jun 2020

      Technical project lead product life cycle on the medically certified software and hardware products. Responsible for the implementation of changes originating from CAPA and non-conformities. Part of the Development department. Also document controller of the product technical files, providing guidance and quality control upon release of new and modified medical electrical equipment or medicalsoftware.

    • Head of the CAPA and Change Management Board
      • Nov 2016 - Jun 2020

      Quality Assurance and Quality Control for change management and CAPA management according ISO 13485:2016. Process responsible for the procedures for Nonconformity, CAPA and Change control. Coordinating the handling of non conformities CAPAs and the release ofnew versions of products for production and distribution.

    • Lead Support Engineer
      • Oct 2014 - Sep 2017

      Leading a department of 4, which provides technical support on Motek Medical's software and hardware products. Coordinating the department: planning, evaluating the KPIs and improving processes for the service department.

  • Motek Medical
    • Amsterdam en omgeving, Nederland
    • Support Engineer
      • Jan 2012 - Oct 2014

  • Vrije Universiteit Amsterdam (VU Amsterdam)
    • Netherlands
    • Higher Education
    • 700 & Above Employee
    • Graduation research
      • 2010 - 2011

      Graduation research for the Master Human movement sciences leading to a publication in Gait & Posture. Mar 19, 2012. Title: 'Attentional demands of cued walking in healthy young and elderly adults.' Graduation research for the Master Human movement sciences leading to a publication in Gait & Posture. Mar 19, 2012. Title: 'Attentional demands of cued walking in healthy young and elderly adults.'

  • Motek Medical B.V.
    • Netherlands
    • Medical Device
    • 1 - 100 Employee
    • Graduation project
      • Mar 2009 - Jul 2009

      Graduation project for the Bachelor Human Kinetic technology. Development of a method for the measurement of the range of motion of the low back in three dimensions during motion with a motion capture system (Highspeed, high resolution infraredcamera's and software, Vicon Motion Systems, Oxford, UK) Graduation project for the Bachelor Human Kinetic technology. Development of a method for the measurement of the range of motion of the low back in three dimensions during motion with a motion capture system (Highspeed, high resolution infraredcamera's and software, Vicon Motion Systems, Oxford, UK)

  • TNO
    • Netherlands
    • Research Services
    • 700 & Above Employee
    • Internship
      • Nov 2008 - Mar 2009

      Development of a measurement set and research into the quality of care, labour efficiency, job satisfaction, and quality of life in a care facility for dementia after the introduction of automation. Development of a measurement set and research into the quality of care, labour efficiency, job satisfaction, and quality of life in a care facility for dementia after the introduction of automation.

  • Erasmus MC
    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Internship
      • Aug 2007 - Nov 2007

      The development of a method for measuring the 3D motion range of the carpometacarpal joint of the thumb with a Mini-Bird system (Magnetic 3D tracking device of Ascention Technology Corporation, Burlington, VT, USA). The development of a method for measuring the 3D motion range of the carpometacarpal joint of the thumb with a Mini-Bird system (Magnetic 3D tracking device of Ascention Technology Corporation, Burlington, VT, USA).

Education

  • Vrije Universiteit Amsterdam (VU Amsterdam)
    Master, Human movement sciences
    2009 - 2011
  • De Haagse Hogeschool / The Hague University of Applied Sciences
    Bachelor, Human Kinetic technology
    2005 - 2009
  • Delft University of Technology
    Bachelor, Mechanical Engineering
    2004 - 2005
  • Het Vlietland College
    VWO, Profile: Natuur & Techniek
    1998 - 2004

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