
Martijn Halbesma
Employee Remediation

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About me
Regulatory & Compliance lead
Education

Drachtster Lyceum
1999 - 2003Atheneum
The University of Auckland
2017 - 2017ENGGEN 771 Medical Devices PracticeThis 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 - 2007Bachelor Management, Economics & Law
Experience

Friesland Bank
Jun 2007 - Sept 2007Employee Remediation
Sogeti
Oct 2007 - Jun 2014Test Engineer / Test Manager
KPN Mobile
Jan 2008 - Jan 2012Responsible 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 2012Test Coordinator (Sogeti)
Jun 2009 - May 2011Test Coordinator (Sogeti)
May 2008 - Jun 2009Test Engineer
Jan 2008 - May 2008

Kadaster
Jan 2012 - Feb 2013Senior 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 2013Senior Test CoordinatorSCRUM 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 2013Test 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 2014Test 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 2014Senior 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 2017Core 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 2017Senior Software Tester
Jul 2014 - Dec 2015

Fisher & Paykel Healthcare
Jan 2017 - Jul 2020Leading 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 2020Quality Systems Engineer
Jan 2017 - Jan 2019

Philips
Jul 2020 - Jun 2021Product Compliance ManagerResponsible 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 2024Senior Group Manager
Oct 2022 - Mar 2024Senior Quality Manager
Jul 2021 - Oct 2022

Philips
Jan 2024 - nowGroup 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 SchoolMar 2019
BiSL Foundation
ExinJan 2013
Agile Foundation
SogetiMay 2012
TMap NEXT® Test Manager
ExinMar 2012
Languages
- duDutch
- enEnglish
- frFrench
- noNorthern frisian
- geGerman
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