Medical Devices Auditor

hace 4 meses

Madrid, España The British Standards Institution (Bsi) A tiempo completo

Great that you're thinking about a career with BSI

Auditor Medical Devices (internally known as Client Manager)

Location: Spain - 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
1) 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
design or design development
servicing, maintenance and or testing
manufacturing or production experience
2) Covering a range of medical devices which could include: Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
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
3) Your experience will also include at least 2 years' working with quality management systems.

4) 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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