Medical Devices Auditor - QMS

BSI Companies; Stazione Masotti; Remoto; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

BSI Companies is seeking an Auditor for the Medical Devices sector who will travel extensively within EMEA to assess compliance with quality management systems. The role requires a strong background in medical devices, including experience with ISO standards and regulatory frameworks. Ideal candidates will have a degree in a STEM field and at least four years of relevant experience. Join a leading organization dedicated to promoting excellence and compliance in medical device safety.

Competenze

• Minimum 4 years of hands-on experience in medical device sectors.
• Experience with active implantable devices and wound care products.
• Minimum 2 years experience with quality management systems.

Mansioni

• Conduct audits independently after training.
• Prepare audit reports and coordinate with client teams.
• Perform audits on-site, remotely, or hybrid.

Conoscenze

Quality Management Systems

Medical Device Standards

ISO 9001

ISO 13485

Client Relationship Management

Regulatory Compliance

Audit Procedures

Formazione

BSc, MSc, or PhD in a related STEM field

Descrizione del lavoro

Apply locations : Italy | Posted : 30+ Days Ago | Job Requisition ID : JR0016196

Great that you're considering a career with BSI!

Role : Auditor Medical Devices (also known as Client Manager)

Location : Italy - Field-based, with 70%-75% travel 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 :

• Initially observe audit procedures during training, then conduct audits independently
• Complete ISO 13485 Lead Auditor training, MDSAP, and MDR
• Conduct audits on-site, remotely, or hybrid, alone or in teams
• Prepare reports and coordinate with planning and delivery teams to manage client relationships and schedules

Minimum requirements :

• At least 4 years of hands-on experience in areas such as research and development, design or design development, servicing, maintenance, testing, manufacturing, or production
• Experience working with a range of medical devices, including :
• Active implantable devices : Cochlear Implants, MEMS systems, infusion pumps, including Software as a Medical Device
• Wound and skin care products : dressings, foams, gels

At least 2 years of experience with quality management systems.

Educational qualifications : A university or technical college 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. Join us to contribute to this inspiring mission—bring your enthusiasm and apply now to become part of the BSI family!

D&I Policy : BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create a sense of belonging, providing growth opportunities and fostering a vibrant, inclusive environment.

Excellence Behaviors : Client-centric, Agile, Collaborative—these principles guide how we operate and ensure BSI remains a great place to work and succeed.

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

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