Auditor & Product Expert for Ivd Expert Devices
hace 2 meses
**General information**:
- Location
- El Prat de Llobregat
- Type of contract
- Permanent
Full Time
- Occupational field
- Auditing & Consulting
- Job-ID
- 5279
- As a Product Specialist/Expert you evaluate IVD Expert medical products in accordance with European guidelines and standards. You are responsible for the review of the technical documentation of selected product groups in non-active products area in your field of expertise - Sterilize and non-sterilize devices, Implantable devices as orthopedic and dental implants, mesh and instruments, etc.
- As an Auditor you primarily conduct audits based on the EC Directive 93/42/EEC, the MDR Regulation, the standard EN ISO 13485 and according to international schemes such as MDSAP and TCP. You compile reports and audit documentation.
**Experience & Further Qualifications**:
- Degree course in Natural Sciences/Biology, Biotechnology, Biomedical Engineering
- Degree course in Natural Sciences/Biology, Biotechnology, Biomedical Engineering
- At least 2 years professional experience in design & development, production, quality assurance, regulatory affairs or quality management of medical devices (related to IVD Expert ).
- Four years of professional experience is a plus, which can be partially substituted by the work at TÜV Rheinland.
- Auditor training is a plus ISO 13485 or ISO 9001.
- Knowledge of relevant guidelines, norms, and product specific standards;
- Fluent in Spanish and English, Portuguese is a plus.
- Local and international business trips are required (depending on job position focus as Auditor and/or Product Expert 20 to 50% per month) and driver’s license.
Working Location/Branch: Barcelona or Madrid
**Location**:
Cl Garrotxa 10-12 Parc de Negocis Mas Blau
08821 El Prat de Llobregat
**Company**:
As an international services group, we want to create a working environment in which all our employees feel secure and comfortable - an environment in which they enjoy giving their best with commitment. The key to this lies in an open, respectful cooperation across all countries, cultures and lifestyles. After all, around 20,000 employees at 500 locations around the globe provide more than 2,500 services. The results of their work can be seen everywhere: in tested elevators or rides, on certified toys or technical equipment, in our consultations or training sessions. No matter where - our international teams have been setting standards in terms of safety, quality and efficiency for many years.
**We value diversity - and take on responsibility**:
Our specialists appreciate this versatile portfolio, the exciting tasks and the value of their work for people, the environment and technology. And we value our specialists for their know-how and commitment, but also for their different personalities and careers. Combined with the professionalism and sense of responsibility of each individual, we create a culture of openness, growth and collegiality. We want to further strengthen this culture and consistently promote respect in our dealings with one another. Not only do we say that, we live that. We have committed ourselves to acting in accordance with the principles of the UN Global Compact initiative, to fighting corruption and to working for human rights, labour standards and environmental protection in our daily work. We are active in numerous networks and projects that stand for diversity and equality. In addition, we have developed a broad range of products and services that help to reconcile the professional and private worlds so that our employees can work in a healthy, motivated and optimal environment.
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