Medical Devices Auditor - Qms

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

Descripción de la vacante

A leading company in medical device auditing is seeking a Client Manager to join their team. The role involves conducting audits, managing client relationships, and ensuring compliance with quality management systems. Candidates should have significant experience in the medical device field and a relevant STEM degree. Join a dynamic team dedicated to excellence and diversity in the workplace.

Formación

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

Responsabilidades

• Conduct audits on-site, remotely, or in hybrid formats.
• Prepare reports and manage client relationships.
• Perform administrative tasks as required.

Conocimientos

Quality management systems

Regulatory compliance

ISO 13485

MDSAP

Medical device experience

Educación

University or technical college degree in STEM

Descripción del empleo

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

We’re seeking talented individuals to join our medical device auditor team. The role involves traveling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits cover 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 :

1. Receive training in ISO 13485 Lead Auditor, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
2. Initially observe audit procedures and then conduct audits independently as you gain experience.

Once fully trained, in a typical week you will :

1. Conduct audits on-site, remotely, or in a hybrid manner, working alone or as part of a team.
2. Prepare reports and coordinate with the planning team and delivery manager to manage client relationships and scheduling.
3. Perform administrative tasks as required.

Minimum Requirements :

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

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

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

• IVD (in vitro diagnostics) instrumentation and reagents
• Active implantable medical 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 products - dressings, foams, gels

3) A minimum of 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 open mindset to our dynamic team. Apply now and join the BSI family!

BSI is committed to diversity and inclusion. We aim to reflect our clients and communities, fostering a sense of belonging and providing growth opportunities for all employees. Join us and thrive.

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Our core behaviors are Client-centric, Agile, and Collaborative—values that guide our work at BSI. They ensure we remain a great place to work and a successful business.

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

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