Medical Devices Auditor - QMS

BSI Companies; Perugia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

BSI Companies is hiring a medical device auditor to join their team, requiring extensive travel throughout EMEA. The role offers training in ISO standards and entails conducting audits for quality management systems within the medical device sector.

Competenze

• Minimum 4 years' experience in R&D, servicing, or manufacturing.
• At least 2 years working with quality management systems.

Mansioni

• Conduct audits on site, remotely, or hybrid after training.
• Write reports and manage audit schedules.

Conoscenze

Quality Management Systems

ISO 9001

ISO 13485

MDSAP

Formazione

BSc, MSc or PhD in Biology, Chemistry, Computer Science, Engineering or related STEM field

Descrizione del lavoro

Location : Italy - field-based, 70%-75% of travel required within EMEA

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

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
• Servicing, maintenance and / or testing
• Manufacturing or production experience

Covering a range of medical devices which could include :

• IVD (invitro diagnostics) instrumentation and / or reagents
• Active Implantable Medical Devices : Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical Device
• Orthopaedics - spinal implants, bone / dental cements, cartilage, and soft tissue repair
• Wound and skin care - dressings, foams, gels

Your experience will also include at least 2 years' working with quality management systems.

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.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries. If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

D&I Policy BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.

LI-DNI

Our Excellence Behaviours : Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

J-18808-Ljbffr