Auditor /Medical Devices/
Your new company
Our multinational client provides certification and testing services for manufacturers and suppliers of medical devices and in vitro diagnostics.
Your new role
• 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 EU Medical Device Regulations (MDR or IVDR), and other QMS certification schemes such as EN-ISO 13485 and MDSAP
• Assessing technical documentation as part of product conformity assessments of Active Medical Devices / Non-Active Medical Devices / IVD Medical Devices according to the requirements of the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Device Regulation (IVDR).
• Preparing deficiency reports in case of non-conformities according to the requirements of the Medical Device Regulation (MDR) / and In Vitro Diagnostic Medical Device Regulation (IVDR).
• Delivering high-quality, reliable, and predictable services within defined timeframes
• Independent supervision of certification projects for our international customers as a project manager
What you'll need to succeed
• University degree in natural sciences or engineering (mechanical engineering, electronic engineering, computer engineering, biology, biotechnology, chemistry / biochemistry, pharmacy, biology, biotechnology, chemistry / biochemistry, pharmacy)
• Fluency in written and spoken English
• Ability to create qualified audit- and deficiency-reports
• Proven qualification as a quality manger is a plus
• 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
• A total of at least four years of professional experience in the field of:
o medical devices industry
o ideally this should be in a role such as manufacturing, quality management, design and development, regulatory affairs or in other institutions carrying out inspections or audits
• Experience in creating or evaluating of the QMS systems and technical documentation for medical devices.
What you'll get in return
Opportunity to work from anywhere in Hungary
High level training
Competitive salary package
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.