Martijn Halbesma

Martijn Halbesma

Employee Remediation

Followers of Martijn Halbesma1000 followers
location of Martijn HalbesmaJoure, Friesland, Netherlands

Connect with Martijn Halbesma to Send Message

Connect

Connect with Martijn Halbesma to Send Message

Connect
  • Timeline

  • About me

    Regulatory & Compliance lead

  • Education

    • Drachtster Lyceum

      1999 - 2003
      Atheneum
    • The University of Auckland

      2017 - 2017
      ENGGEN 771 Medical Devices Practice

      This course covers the practical aspects of medical device design including regulatory requirements, international standards, safety and ethical issues, quality control and manufacturing.

    • Noordelijke Hogeschool Leeuwarden

      2003 - 2007
      Bachelor Management, Economics & Law
  • Experience

    • Friesland Bank

      Jun 2007 - Sept 2007
      Employee Remediation
    • Sogeti

      Oct 2007 - Jun 2014
      Test Engineer / Test Manager
    • KPN Mobile

      Jan 2008 - Jan 2012

      Responsible for executing system tests, system integration tests and chain tests. Organized user acceptance tests. I was responsible for coordinating a large fiber project in a very political and dynamic envorinment. Coordinating system integration tests and chain tests in a complex and dynamic environment. Establishing new platform for business internet and phone in a competitive market resulting in high pressure to deliver in time. Coordinating transition of test activities performed onshore to offshore (India). Test execution activities at a large telecommunications company. Testing billing platform and responsible for test environment. Setup regression tests and international reporting, applying to international reporting requirements (SOX).

      • Senior Test Coordinator (Sogeti)

        May 2011 - Jan 2012
      • Test Coordinator (Sogeti)

        Jun 2009 - May 2011
      • Test Coordinator (Sogeti)

        May 2008 - Jun 2009
      • Test Engineer

        Jan 2008 - May 2008
    • Kadaster

      Jan 2012 - Feb 2013
      Senior Test Coordinator (Sogeti)

      Coordinating multiple projects at the Netherlands’ Cadastre, Land Registry and Mapping Agency. Creating support in the organization and multiple external stakeholders for introduction of projects. Gained experience with SAP and tools like ClearQuest and JIRA.

    • AEGON Nederland

      Feb 2013 - Jul 2013
      Senior Test Coordinator

      SCRUM project, responsible for processing change requests and defect management, testing releases, creating test planning and communication with users. Hosting demonstrations to users, management and other stakeholders to show product functionality. Coordinating role in implementation of various sprints, resulting in a new online customer portal and new services and possibilities for the customer.

    • KPN Mobile

      Jul 2013 - Oct 2013
      Test Manager (Sogeti)

      Responsible for replacing a complete prepaid platform. Enhancing the awareness in the organization by organizing demonstrations, workshops and user acceptance tests. Also responsible for friendly user pilot, consisting of a large production acceptance test involving 200 users. Managing complex dependencies with a migration project of the existing customer portfolio to the new platform. Intensive and timely alignment with customers.

    • Cendris

      Dec 2013 - Jan 2014
      Test Manager (Sogeti)

      Professionalizing the test organization of a major postal company. Enhancing data quality of customers by creating concrete agreements with suppliers, introducing regression tests and introducing test tools in the area of test execution and defect management. Documented in a master test plan resulting in time saving, better collaboration with suppliers and less failures in production.

    • Canon Europe Ltd.

      Feb 2014 - Jun 2014
      Senior Test Coordinator (Sogeti)

      Coordination of test project for a Master Data Management system. Working with onshore and offshore colleagues. Defect management, reporting to management.

    • BD Kiestra

      Jul 2014 - Jan 2017

      Core team member for R&D for a large new instrument. Responsible for R&D project team with mechanical, electrical and software engineers using GPDS project phasing and Agile/SCRUM method. Translating user requirements (Voice of Customer/Voice of Business) to product requirements, system specifications and detailed specifications. Performing risk management, budgeting and planning (by creating Work Breakdown Structure) and creating and evaluating metrics. Also responsible for integration of the new instrument with existing and future developed systems by creating roadmaps and responsible for development user interface design. High collaboration with stakeholders. Show less Responsible for all verification and validation activities of a large new product development project and multiple continuous improvement projects (existing instruments and applications). Creating and executing V&V plans, protocols and summaries, based on performed risk assessments. Defining, selecting and implementing test strategies, test tools and performance tests. Gained experience with tools like Team Foundation Server, Cognition Cockpit and gained knowledge concerning QA, Quality Controls, microbiology lab automation and mechanical/electrical engineering Show less

      • System Integrator

        Jan 2016 - Jan 2017
      • Senior Software Tester

        Jul 2014 - Dec 2015
    • Fisher & Paykel Healthcare

      Jan 2017 - Jul 2020

      Leading Quality Engineering teams and responsible for meeting legal compliance and user needs for medical devices during product development. Representing Quality as core team member responsible for implementing EU Medical Device Regulations (MDR) across the business by creating, updating and implementing processes in the QMS, updating risk management and post-market procedures, reviewing clinical evaluation documentation. Specifically focusing on medical device software, health apps and product cybersecurity. Show less Partnering with the Research, Development and Operations teams to contribute to market acceptance of newly developed products by using technical expertise, leadership and pragmatism to influence product quality.Key responsibilities include leading the activities throughout the product development process. From early feasibility to product commercialization, to managing the implementation of the Quality Management System (QMS). Ensuring the right products are being designed and able to be manufactured reliably whilst maintaining compliance. Show less

      • Quality Systems Engineering Manager - Design

        Feb 2019 - Jul 2020
      • Quality Systems Engineer

        Jan 2017 - Jan 2019
    • Philips

      Jul 2020 - Jun 2021
      Product Compliance Manager

      Responsible for compliance of all Philips Personal Health products with all the relevant regulations, standards and safety and environmental policies before they are released to the market.

    • Fisher & Paykel Healthcare

      Jul 2021 - Mar 2024
      • Senior Group Manager

        Oct 2022 - Mar 2024
      • Senior Quality Manager

        Jul 2021 - Oct 2022
    • Philips

      Jan 2024 - now
      Group Lead Regulatory & Compliance G&B Personal Health
  • Licenses & Certifications

    • ISTQB Foundation

      Exin
    • ITIL Foundation

      Exin
    • Prince2 Foundation

      Exin
    • TMap NEXT® Foundation

      Sogeti
    • Management Fundamentals

      The University of Auckland Business School
      Mar 2019
    • BiSL Foundation

      Exin
      Jan 2013
    • Agile Foundation

      Sogeti
      May 2012
    • TMap NEXT® Test Manager

      Exin
      Mar 2012