Medical Devices Auditor - QMS

BSI Companies; Albacete; Híbrido; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Ein dynamisches Unternehmen sucht nach talentierten Fachkräften für die Rolle des Medizinprodukte-Auditors. Diese spannende Position erfordert Reisen zu verschiedenen Standorten, um Qualitätssysteme zu bewerten und die Patientensicherheit sowie die regulatorische Compliance zu unterstützen. Sie werden umfassend in ISO 13485 und MDSAP geschult, bevor Sie eigenständig Audits durchführen. Wenn Sie eine Leidenschaft für Exzellenz in der Medizinproduktebranche haben und in einem vielfältigen Team arbeiten möchten, ist dies die richtige Gelegenheit für Sie.

Formación

• Mindestens 4 Jahre Erfahrung in der Forschung, Wartung oder Herstellung von Medizinprodukten.
• Mindestens 2 Jahre Erfahrung mit Qualitätsmanagementsystemen.

Responsabilidades

• Durchführung von Audits vor Ort, remote oder hybrid, allein oder im Team.
• Vorbereitung von Berichten und Koordination mit dem Planungsteam.

Conocimientos

Qualitätsmanagementsysteme

ISO 13485

MDSAP

Medizinprodukte

Auditor Training

Educación

BSc in Biologie

MSc in Biochemie

PhD in Bioengineering

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 assist with 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, and MDR (Medical Device Regulation).
• Initially observe audits, then conduct them independently as you gain experience.

Once fully trained, your typical week will include :

• Conducting audits onsite, remotely, or in a hybrid manner, alone or with a team.
• Preparing reports and coordinating with the planning team and delivery manager to manage clients and schedules.
• Performing administrative tasks as needed.

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, such as :

• IVD (in vitro diagnostics) instrumentation and reagents
• Active implantable devices like 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) At least 2 years' experience working with quality management systems.

4) A university or technical degree (BSc, MSc, or PhD) in a related 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 across more than 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family!

BSI is committed to diversity and inclusion, reflecting the communities we serve. We aim to create a sense of belonging by offering opportunities for growth, development, and engagement within our global organization, all while having fun doing meaningful work. Everyone can thrive at BSI.

LI-DNI

Our core behaviors are Client-centric, Agile, and 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.