Medical Devices Auditor - QMS

BSI Companies; Barcelona; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in medical device auditing seeks a Client Manager to join their team. The role involves conducting audits of quality management systems across various medical devices, ensuring compliance with standards like ISO 13485. Candidates should have significant experience in the field and a relevant STEM degree. Join a diverse and inclusive environment where excellence is the goal.

Formación

• Minimum 4 years' experience in R&D, servicing, or manufacturing of medical devices.
• At least 2 years' experience with quality management systems.
• Experience with IVD and active implantable devices.

Responsabilidades

• Conduct on-site, remote, or hybrid audits.
• Write reports and manage client schedules.
• Complete administrative tasks as needed.

Conocimientos

Quality management systems

Auditing

Client management

Regulatory compliance

Educación

University or technical college degree in STEM

Descripción del empleo

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

We’re looking for talented individuals 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 like MDSAP. We also support conformity assessment activities related to UKCA and CE marking.

Responsibilities :

In the first six months as a Client Manager, you will :

• Receive training in ISO 13485 Lead Auditor, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
• Initially observe audit procedures, then progress to conducting audits independently.

After full training, a typical week includes :

• Conducting on-site, remote, or hybrid audits alone or as part of a team.
• Writing reports and coordinating with the planning team and delivery manager to manage clients and schedules.
• Completing administrative tasks as needed.

Minimum Requirements :

1) A minimum of 4 years' hands-on experience in at least one of the following areas :

• Research and development
• Servicing, maintenance, or testing
• Manufacturing or production

2) Experience covering a range of medical devices, including :

• IVD (in vitro diagnostics) instrumentation and reagents
• Active implantable devices like cochlear implants, MEMS systems, infusion pumps, including software as a medical device
• Orthopaedics such as spinal implants, bone/dental cements, cartilage, soft tissue repair
• Wound and skin care products like dressings, foams, gels

3) At least 2 years' experience working with quality management systems.

4) A university or technical college degree or equivalent in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, 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 over 100 years of experience. We partner with 86,000 companies and organizations across more than 193 countries. If you are inspired by this mission, bring your enthusiasm and apply now to join the BSI family!

Our D&I Policy: BSI is committed to a diverse workforce that reflects our clients and communities. We aim to foster a sense of belonging and provide opportunities for growth, development, and engagement in a fun, inclusive environment. Everyone can thrive here.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a great workplace and successful business.

We conduct face-to-face interviews where appropriate. If invited to an in-person interview but prefer a virtual one, please discuss this with our recruitment team.

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