Auditor for IVD Medical Devices

Place of work
 Home Office / Slovak Republic

Contract type
Full-time

Starting date
ASAP

Salary
2 800 euro/brutto (depending on the experience of the candidate)

We offer: 

• Employment based on employment contract (Full-time / Permanent )
• Access to employee benefits package (including medical care, life insurance, sports & culture card, co-financing for language learning and leisure)
• Opportunity to gain valuable work experience
• Work in a group of specialists in a company with established position on the market
• Friendly working atmosphere
• Necessary work tools
• Possibility to work remotely

Responsibilities: 

• Performing onsite Audits at manufacturer’s premises (approximately 50% travel required for this role)
• Auditing Quality Management Systems in accordance with the requirements of the In Vitro Diagnostic Medical Devices Regulation, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
• Assessing Technical Documentation as part of product conformity assessments of IVD Medical Devices according to the requirements of the IVDR 2017/746
• Preparing reports included deficiency reports in case of non-conformities according to the requirements of the ISO 13485, ISO 9001, IVDR and MDSAP standards
• Delivering high-quality, reliable, and predictable services within defined timeframes
• Independent supervision of certification projects for our international customers as a project manager
• Readiness for intensive familiarisation with the ISO 13485, ISO 9001, IVDR and MDSAP standards

Qualifications: 

• University degree in technical or scientific studies, e.g. biology, biochemistry, biotechnology or comparable field of study
• At least four years of professional experience in the manufacturing environment of the health care sector, e.g. with a manufacturer of medical devices
• Technical product knowledge in the field of medical technology
• Fluency in written and spoken English
• Proven qualification as an auditor or quality manger is a plus
• Sound knowledge of quality management or regulatory affairs according to ISO 13485 and ISO 9001
• Excellent organisational and professional communication skills
• Ability to work in a team, pronounced customer orientation and good self-organization
• Curiosity and willingness to learn
• Experience working with MS Office applications and programs
• Full and valid driving licence

 Fill iin this short questionare and we will contact you!

EMPLOYEE PERKS, BENEFITS

• employment in a large international company
• pleasant working environment, professional approach of colleagues
• space for self-realization, personal growth, further education and training
• wide range of benefits - salary bonuses, language courses, Sick days, employer's contribution to pension savings

  ---

Language skills:

• English - Advanced (C1)
• Highly proficient in spoken and written English. German language knowledge is a plus.

Other knowledge:

Mcrosoft Excel - advanced
Microsoft Word - advanced
Microsoft Outlook - advanced
Microsoft PowerPoint - basic

Number of years of experience:
4

INFORMATION ABOUT THE SELECTION PROCESS

Please send your CV in Slovak and English language. We will only contact selected candidates for a personal interview. We thank all the candidates for their interest in working for our company.

The basic salary and possibility of increase will be the subject of a personal interview depending on the professional experience and experience of the applicant. It is possible to work from home or from any of our branches e.g. Košice, Bratislava, Banská Bystrica, Nitra.

By sending your CV, motivation letter and other appendices related to the selection procedure, you give TÜV SÜD Slovakia sro, Jašíkova 6, 821 03 Bratislava, e-mail: [email protected], IČO: 35852216, responsible person (DPO): Ing . Katarína Matejčíková, e-mail: [email protected], consent to the processing of your personal data listed in the CV and the application for admission and other attachments related to the application for employment for the purposes of selection and registration in the internal database of candidates for employment in our company.
This consent is voluntary and is valid until revoked, but no longer than two years from its provision or until the date of signing the relevant employment contract / agreement on work performed outside the employment relationship with TÜV SÜD Slovakia s.r.o .., after this period they will be immediately liquidated.
The consent can be revoked at any time by sending a written revocation of the consent to the address of the registered office of TÜV SÜD Slovakia s.r.o .: Jašíkova 6, 821 03 Bratislava. The validity of the processing of personal data on the basis of this consent before the withdrawal of the consent remains unaffected.
At the same time, we inform you that according to § 19 par. 2 letter b), c) and d) of Act no. 18/2018 Coll. on the protection of personal data and on the amendment of certain laws, you have the right to request from TÜV SÜD Slovakia s.r.o. access to your personal data, the right to correct, delete and restrict the processing of your personal data, the right to object to the processing of personal data, the right to the transfer of personal data and the right to file a complaint (motion to initiate proceedings under Section 100 of Act No. 18/2018 Coll. z.) to the Office for Personal Data Protection of the Slovak Republic, with its registered office at Hraničná 12, 820 07 Bratislava 27, Slovak Republic, or to contact the Office via its website www.dataprotection.gov.sk.
The job seeker is responsible for the accuracy and veracity of the personal data provided to TÜV SÜD Slovakia s.r.o..

Send us your CV to [email protected]