Medical Devices Auditor - Active, Software. Dutch speaking

We exist to create positive change for people and the planet. Join us and make a difference too! Medical Devices Auditor (internally known as Client Manager) - High Risk Software Location: The Nethederlands- field-based, 70%-75% of travel required within EMEA   About the role We’re looking for talented people to join our medical device auditor team. The role involves travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as ISO 9001 / ISO 13485 and schemes such as MDSAP.  We also support conformity assessment activities such as those related to UKCA and CE marking.   Responsibilities: In the first six months of being a Client Manager, you will: Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation) Initially observe how audits are conducted but then grow to conduct them on an individual basis In a typical week after being fully trained, you will: Conduct an audit on site, remotely or hybrid, working alone or as part of a team Write up your reports and liaise with the planning team and delivery manager to manage your clients and audit schedule Complete other administrative activities as required 1) To be successful you need to have a minimum of 4 years hands on experience in one or more of the following areas: research and development  design or design development;  servicing, maintenance and or testing;  manufacturing or production experience. 2) Covering a range of medical devices which could include: Active/SaMD: X-rays, Heart Lung machines, Defibrillators, MRI Scanners, AI devices 3) Your experience will also include at least 2 years' working with quality management systems.   4) You must have completed a university or technical college degree or equivalent in a related STEM subject (BSc, MSc or PhD) such as: Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, or Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics 5) Native or high level of Dutch and English BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 27-days annual leave, paid sick leave, bank holidays, pension plan, company car, healthcare allowance, paid maternity leave, paid paternity leave, paid parental leave, paid emergency leave, paid short-term care leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.  The salary for this position can range from €70,000 to €88,000 annually. #LI-LH1 #LI-Onsite About Us BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive…