Beschreibung

Auditors, Technical & Clinical Experts

Domanda

Se interessato, invia il tuo Curriculum Vitae a info@mtic-group.org

About the job

MTIC Group, Multinational Group which provides services as Notified body and Accredited Certification Body by its member companies, is growing steadily and successfully in all areas of testing, inspection, and certification.

Currently, we are looking for a Medical Devices Certification Officer for our office InterCert GmbH – Group of MTIC -, in Bonn, Germany.

Main responsibilities:

Delivering Medical Device CE Marking and ISO 13845 scheme management

To carry out the quotation, contract, processes review and compile certification decisions under the CE and ISO 13485 certification schemes
To review assessment reports and other relevant documents.
To support the Medical Device Certification office members through the certification, surveillance and renewal processes.
qualification of the experts and auditors

Delegate responsibilities and supervise the work of executives providing guidance and motivation to drive maximum performance
Organize workflow to meet specifications and deadlines
Monitor process to resolve issues

Minimum Requirements:

University degree (or equivalent qualification) in a relevant scientific or engineering discipline
Work experience of minimum 4 years in CE marking, Medical Device Directive (93/42/EEC), Medical Device Regulation (Regulation (EU) 2017/745), ISO 13485 for other NBs and excellent knowledge of certification process
Excellent knowledge of the main horizontal harmonized standards
Very good knowledge of English

Additional requirements:

Strong decision-making skills and a results-driven approach
Problem-solving skills
Outstanding communication ability and interpersonal skills
Excellent organizational and leaderships skills
Attention to detail

Dati dell’azienda

INTERCERT GmbH – Group of MTIC –

Am Bonner Bogen 2, 53227 Bonn, Deutschland

t. +49 228 62 9750-0

info@mtic-group.org

VAT Number: DE260303555