Revisor - Medicinsk utrustning / Medical Device Auditor

Revisor - Medicinsk utrustning – Active & Software
Sverige– Fältbaserad
As a Medical Device Auditor, you’ll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You’ll 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.
In the first six months of being a Medical Device Auditor you’ll be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation. You’ll initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office
In a typical week after being fully trained you’ll: Conduct an audit on site or remotely and write up your reports and liaise with the planning team to manage your audit schedule. You’ll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.
To thrive in this career, you must:
· Have 4 years or more being directly accountable for the design or test or manufacture of active medical devices
· Be degree educated with discipline relevant to active devices e.g. electro-mechanical, electronic/electrical, biomedical engineering or similar
· Demonstrate your experience with the software development lifecycle (ISO 62304/IEC 62366)
· Have at least 2 years’ experience working in an environment with a Quality Management System established
· Be able to speak and write fluently in Swedish (or other Nordic region dialects) and English languages
· Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required
We’re enthusiastic to receive applications from those based in Sweden excited by this career opportunity.