Medical Devices Auditor - Qms

buscojobs España; Murcia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the medical device sector seeks a Client Manager to join their team. This role involves conducting audits and ensuring compliance with quality management systems across various medical devices. Ideal candidates will have extensive experience in the field and a strong educational background in STEM. If you are passionate about excellence and patient safety, apply to be part of a dynamic team.

Formación

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

Responsabilidades

• Conduct audits onsite, remotely, or in hybrid formats.
• Prepare reports and manage client schedules.
• Perform administrative tasks as needed.

Conocimientos

Quality Management Systems

Medical Device Knowledge

Auditing

Client Management

Educación

University or technical college degree in a STEM field

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 such as 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, in a typical week, you will :

• Conduct audits onsite, remotely, or in hybrid formats, independently or within a team.
• Prepare reports and coordinate with the planning team and delivery manager to manage clients and schedules.
• Perform other administrative tasks as needed.

Minimum Requirements :

1) At least 4 years of practical experience in one or more of the following areas :

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

2) Experience covering a range of medical devices including :

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

3) Minimum of 2 years working with quality management systems.

4) A university or technical college degree 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 193 countries. If you are inspired to contribute to this mission, bring your enthusiasm and apply to join our dynamic team and become part of the BSI family!

Our D&I Policy: BSI is committed to workforce diversity, reflecting our clients and communities. We aim to foster a sense of belonging for all employees by providing growth opportunities, engagement, and a fun, productive environment. Everyone can thrive here.

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Our Excellence Behaviors: 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 feasible. If invited but more comfortable with virtual interviews, please inform our recruitment team.

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