Non-active Medical Device Auditor

Breve introduzione: Are you a specialist in the medical or medical devices sector? Have you ever thought of using your specialism to contribute to the safety and performance of medical devices according to the European Medical Device Regulation? Do you want to further build on your experience in an ambitious international company? Then you might well be Kiwa’s new Non-active medical device auditor Descrizione del ruolo:
In the role of Lead auditor, you are responsible for performing audits on quality management systems of manufacturers and suppliers of active medical devices. You will perform audits at organizations according to the Medical Device Regulations (MDR) and the EN-ISO 13485 standard. Our clients range from highly innovative start-ups to large companies, both national and international with a wide range of medical devices.

After an extensive internal training program, you:

- Execute audits independently as a Lead auditor;
- Are responsible for the audit activities of your customers;
- Maintain frequent contact with the customer concerning the audit activities and follow up;
- Act as a linking pin and maintain frequent contact with your customers, colleagues, external experts and contractors;
- Provide advise and mentoring to colleagues in your area of competence;
- Will travel approximately 40-70% of your time, both national and international.

When you have sufficient working experience with specific types of devices, you may also take up the role of Technical File reviewer in combination with auditing. In this role, Clinical Evaluation assessments may be part of your work.

Cosa ci aspettiamo da voi:
You want to take a new step in your career and are interested to further develop your knowledge and skills. You are ready to receive an internal training program to become qualified as Kiwa Medical Device Lead auditor under the applicable regulations and standards. You get energy from contributing to the quality and safety of products. You can work independently as well as in a team and take ownership for your work scheduling workloads to make best use of own time and the completion of chargeable work assigned in the timeframe. You have good communication skills, informing and reporting to stakeholders in a clear and timely manner.

For this position, we’d like you to bring these educational and personal skills:

- A PhD., MSc. or BSc. in a relevant engineering or sciences discipline, for example biomedical, electrical or mechanical engineering, pharmacy, physics, information technology;
- A minimum of 4 years’ experience in the in the field of healthcare products or related activities, such as in manufacturing, auditing, assessment or research of which a minimum of 2 years in Quality Management and Regulatory Affairs, which may be gained as part based of a quality and regulatory team;
- Experience with specific production technologies such as metal, non-metal processing, plastic processing, chemical processing, biotechnology and pharmaceutical processing is highly valued;
- Experience with non-active medical devices such as Orthopaedics, spinal implants, bone cements, Dental implants, dental cements, bone substitutive, soft tissue implant, Wound and skin care, substances ‘based device including medicinal product, animal tissue or derivatives, drug combinations device, non-active, non-implantable devices as catheter, guidewires, needle, syringes is valued;
- Appropriate knowledge on harmonized medical device standards, CS and MDCG documents for non-active devices;
- Experience with risk management according to ISO 14971;
- Experience with quality management systems (ISO 13485, MDR) and related standards and guidance documents;
- Third party Auditing experience made by a Certification Body related to the MDR and/or EN-ISO 13485 is considered an advantage;
- Fluent in English language skills are required, German/French/Spanish language knowledge is valued;
- You are based in Italy and are entitled to work here;
- Be resilient and able to meet audit delivery by travelling frequently across EMEA and also Extra -EU.

Cosa offriamo noi in cambio:
As an Auditor Medical Devices at Kiwa, you’ll hold a challenging position in an internationally oriented, ambitious, expanding Notified Body organisation. At Kiwa, we value your professional development and personal wellbeing. When it comes to our terms and conditions, we offer you a salary tailored to your professional competence and experience, including important benefits such as:

- company car provided
- luncheon vouchers
- annual welfare vouchers
- additional health insurance
- Comprehensive training programme
- Eligible for Career pathways

**Where you’ll work**
In this role, you will work for Kiwa Cermet Italia, based in Cadriano (BO). You will be part of the Medical Devices team: a friendly, close-knit, professional team made up by over 30 very skilled people. Your job tasks will require frequent travels in Italy and abroad, but when you