Medical Device Auditor QMS (m/f/x)

Medical Device Auditor QMS (m/f/x)

Location: Germany – 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:

1. Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation).
2. 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:

1. Conduct an audit on site, remotely or hybrid, working alone or as part of a team.
2. Write up your reports and liaise with the planning team and delivery manager to manage your clients and audit schedule.
3. 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:

1. Research and development.
2. Design or design development.
3. Servicing, maintenance and/or testing.
4. Manufacturing or production experience.

Covering a range of medical devices which could include:

1. Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners.
2. IVD (invitro diagnostics) instrumentation and/or reagents.
3. Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical Device.
4. Orthopaedics – spinal implants, bone/dental cements, cartilage, and soft tissue repair.
5. 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.

Do you believe the world deserves excellence?

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!

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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.

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