Medical Devices Auditor - QMS

BSI Companies; Ferrara; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

BSI Companies is seeking a Medical Devices Auditor to join their team, involving significant travel across EMEA. Ideal candidates will have extensive experience in quality management systems and a relevant STEM degree, ready to ensure compliance and safety in the medical devices sector.

Competenze

• At least 4 years of hands-on experience in R&D, servicing, or manufacturing.
• Experience with medical devices or related products.
• Minimum 2 years with quality management systems.

Mansioni

• Conduct audits onsite, remotely, or hybrid, and lead audit processes.
• Prepare reports and coordinate with teams for client management.
• Perform administrative tasks as required.

Conoscenze

Quality Management Systems

Auditing

Regulatory Compliance

Formazione

Degree in STEM field (Biology, Microbiology, etc.)

Descrizione del lavoro

Medical Devices Auditor - QMS

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

Great that you're considering a career with BSI!

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

Location: Italy - field-based, with 70%-75% travel within EMEA

We are 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 assessments 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

Post-training, your weekly activities will include:

• Conducting audits onsite, remotely, or in a hybrid manner, alone or with a team
• Writing reports and coordinating with planning and delivery teams to manage clients and schedules
• Performing administrative tasks as required

Minimum requirements:

1. At least 4 years of hands-on experience in areas such as research and development, servicing, maintenance/testing, or manufacturing/production
2. Experience covering medical devices like IVD instrumentation/reagents, active implantable devices, orthopaedics, or wound care products
3. At least 2 years' experience with quality management systems
4. Degree or equivalent in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer/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 over 86,000 companies across 193 countries. If you are inspired by this mission, bring your enthusiasm and apply now to join the BSI family!

Diversity & Inclusion Policy:

BSI is committed to reflecting the diversity of our clients and communities. We aim to create an inclusive environment where everyone can thrive, grow, and engage while enjoying their work.

Additional Information:

We conduct face-to-face interviews where appropriate. If invited but more comfortable interviewing virtually, please discuss this with our recruitment team.

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