Senior Technical Certifier in the field of certification of in-vitro diagnostic medical devices (f/m/d)
TÜV SÜD
München, Bayern
vor 5 Tg.

Aufgaben

Handling of certification processes and conformity evaluation processes according to IVDD and / or IVDR in the field of IVD medical products

Assuring the application of the QM system in the department

Representing the department in front of external actors within the framework of talks, lectures and meetings with clients

Clarifying technical questions raised by project leaders, auditors, experts in the field and clients on behalf of certification managers

Technical handling of appeals from clients

Supporting the certification body’s management in formulating replies to queries and requests by competent authorities

Supporting the certification body’s management in the organisation of audits by the authorities and assisting in surveys or evaluations in audits carried out by the authorities

Maintaining the authorisations through the review of technical documentations of IVD products as well as the execution of audits, including the technical reports associated with such audits

Carrying out technical evaluations and making the final decision regarding certifications and maintenance of certification

Supporting projects in the frameworks of the maintenance of the TÜV SÜD Product Service GmbH accreditation / designation

Conducting internal audits at TÜV SÜD Product Service GmbH’s international certification branches

Technical processing of client vigilance information and incidents

Supporting, training and monitoring of technical certifiers

Qualifikationen

Master s or engineering degree in a natural sciences discipline such as biochemistry, biotechnology, chemistry etc.

At least 4-5 years of experience in the field of medical devices and / or related services and / or at least 4-5 years of experience working at notified body

Preferably background working as a technological auditor or technical assessor in the field of in-vitro diagnostic medical devices (high-risk and medium-risk of in-vitro diagnostic products acc.

to IVDD possibly also IVDR)

Knowledge of quality standards and accreditation models especially ISO / IEC 17065, ISO 17020, ISO 17021, ISO 17025, MDSAP

Strong unterstanding of regulations and standards and how they are to be interpreted

Good English and German skills

Willingness to travel (up to 10-15% of working time), also internationally

Skills in Microsoft applications

Ability to work both independently and in a team

Strong work ethics and social competence as well as client service skills to ensure an effective and responsive interaction with clients (internal and external)

Ablily to mantain composure and work well under pressure in challenging situations and to ensure compliance with regulations and protection of business interests

Cultural sensitivity and openness

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