Experience

SinQS in Medical Devices

• Netherlands
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Consultant and Person Responsible for Regulatory Compliance

  • Apr 2020 - Present

  - Person Responsible for Regulatory Compliance (Ad interim) - Management Representative (Ad interim) - Consultant QMS, Auditing, Technical Documentation and related activities for Medical Devices (EU, MDSAP) - Person Responsible for Regulatory Compliance (Ad interim) - Management Representative (Ad interim) - Consultant QMS, Auditing, Technical Documentation and related activities for Medical Devices (EU, MDSAP)



Bevaplast BV

• Netherlands
• Medical Device
• 1 - 100 Employee

• PRRC & MR

  • Apr 2020 - Dec 2022

  - Person Responsible for Regulatory Compliance - Management Representative - Person Responsible for Regulatory Compliance - Management Representative



MDProject

• Netherlands
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Consultant Medical Devices

  • Sep 2017 - Apr 2020

  As a senior consultant, with over 20 years of experience and knowledge of the medical device industry and it's regulatory requirements, I am able help the clients of MD Project with quality management systems, medical device and related challenges to ensure appropriate implementation of the applicable requirements for their business needs. As a senior consultant, with over 20 years of experience and knowledge of the medical device industry and it's regulatory requirements, I am able help the clients of MD Project with quality management systems, medical device and related challenges to ensure appropriate implementation of the applicable requirements for their business needs.



DEKRA Certification B.V.

• Netherlands
• Automotive
• 1 - 100 Employee

• Project Manager

  • Nov 2014 - Sep 2017

  Lead auditor ISO 13485 including CMDCAS Notified Body Lead auditor (MDD) Lead auditor ISO 13485 including CMDCAS Notified Body Lead auditor (MDD)



Philips

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Senior Director Q&R interventional X-Ray

  • Aug 2011 - 2014

  Q&R interventional X-Ray Q&R site Best Q&R interventional X-Ray Q&R site Best



Fresenius Kabi

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Quality Assurance and Regulatory Affairs

  • Aug 2008 - 2011

  Global Operations Medical Devices Transfusion Technology Global Operations Medical Devices Transfusion Technology



Fresenius HemoCare Netherlands B.V.

• Director Quality Assurance and Regulatory Affairs

  • Mar 2007 - 2008

  Site responsible Site responsible



Cordis

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• QA manager

  • 2003 - 2007

  Managing operational QA

• QA manager

  • 1996 - 2003

  Operational QA

• QA engineer

  • 1993 - 1996

  Operational QA