ICR Polska Ltd. started operations in 2014 as the European branch of ICR Co. Ltd, an international research and certification entity based in Seoul, South Korea.
We have extensive activities in the area of TIC - Testing-Inspection-Certification at home and abroad.
ICR Poland has recently undergone an assessment for certification of medical devices according to Regulation 2017/745 - MDR, hence the search for people with experience and a parallel desire to develop in the above area.
Medical Device Certification Specialist
Place of work: Warsaw, full-time
- Carry out formal and substantive evaluation of medical device documentation,
- Selection and supervision of experts carrying out a particular stage of certification,
- Conducting on-site audits at the client's premises (willingness to travel, including abroad),
- Working closely with current clients and potential clients,
- Minimum of 3 years substantive experience in the area of medical devices,
- University degree in medicine, biotechnology, medicinal chemistry, medical analytics, biomedical engineering, materials engineering and related disciplines,
- Knowledge of legal and normative requirements for medical devices for CE purposes,
- Knowledge of quality management systems,
- Knowledge of English at an advanced level,
- employment under an employment contract,
- fixed salary and performance-related bonus,
- Opportunities for professional development through training and working in a dynamic international organisation,
Management Systems Certification Specialist
- organising and keeping records of certification and supervision processes
- acquisition and cooperation with customers
- cooperation and supervision of auditors/experts
- cooperation with national and foreign customers
- technical university degree
- min. 2 years' experience in a similar position, or in a technical position in the area of production, design or research
- knowledge of the ISO 9001, 14001, 13485 series of standards
- sufficient knowledge of the English language to be able to evaluate technical product documentation, communicate with customers
- knowledge of ISO/IEC 17021 and ISO/IEC 17065 would be an advantage
- contractual or B2B employment
- working in a dynamic company and participating in interesting projects
- flexible starting times (between 7.00 - 8.30 a.m.),
- Opportunity for professional development in an international expert environment in a relaxed atmosphere,
- specialised training to maintain and develop your entitlements
- remuneration commensurate with competence
When sending your application, please include your written consent:
I agree to the processing of my personal data contained in my application documents by ICR Polska Sp. z o. o. for the purposes necessary for the recruitment process. Notwithstanding the above, we would like to inform you that the Data Administrator reserves the right to contact selected persons who meet the criteria specified in the advertisement. At the same time, we provide you with information regarding the processing of your personal data in our recruitments taking place in accordance with the Regulation of the European Parliament and of the Council (EU) 2016/679 of 27 April 2016 on the protection of natural persons in relation to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), hereinafter referred to as RODO:
- The administrator of your personal data indicated in your application documents is ICR Polska Sp. z o.o. with its registered office in Warsaw 03-944, Plac Przymierza 6, hereinafter referred to as Data Administrator.
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