Auditor - Medical Devices

Location: Poland - fieldbased, 70%-75% of travel required within EMEA

As a Client Manager in Regulatory Services, you will travel to medical device manufacturers across Poland 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:

• 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

In a typical week after being fully trained, you will:

• 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.

To be successful in the role, you will have:

• 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 and Polish. We also welcome those with additional language skills

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 20-days annual leave, paid sick leave, bank holidays, life health insurance, life insurance, pension plan with company contribution, company car, social fund, remote working allowance, paid maternity leave, paid paternity leave, paid parental leave, paid wedding leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.