- 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 on site at medical device manufacturers across EMEIA and remotely from your home office
- Conduct an audit on site, remotely or hybrid
- Write up your reports and liaise with the planning team to manage your audit schedule.
- Continue your development of MDR and be an advocate for the ISO 13485 EMEIA Delivery Team.
- A Bachelor's Degree in a STEM area
- At least 4 years of full-time work experience in the medical devices industry. This experience must be within product realization where you have been responsible for either the Design, R&D and/or Manufacturing and/or Servicing/Repair or production engineering
- At least 2 years' experience working in an environment with a Quality Management System established
- Ability to speak and write fluently in English. We also welcome those with additional language skills
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Medical Devices Auditor - Nederland - BSI Group The Netherlands B.V.
Beschrijving
About BSIBSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services RS) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands and United Kingdom and is an accredited ISO 13485 Certification Body recognised in many global markets.
Auditor Medical Devices (internally known as Client Manager)
Location: Netherlands - fieldbased, 70%-75% of travel required within EMEA
As a Client Manager in Regulatory Services, you will travel to medical device manufacturers across the Netherlands and EMEA. You will help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.
Responsibilities:
In the first six months of being a Client Manager, you will: