MedRes is an internationally experienced company with nearly 20 years of experience in the development and manufacture of minimally invasive medical devices, which are sold internationally.
Our aim is to minimise the surgical risk during various surgical procedures so that patients can achieve a better quality of life after surgery.
As a technology-focused medical device company, we ensure the highest quality standards in our research, development and manufacturing processes. Our processes adhere to industry standards such as ISO 13485 and FDA regulations and guidelines.
Main tasks:
- Actively participate in the design, review and development of the company’s processes.
- Ensure compliance with and enforcement of regulatory requirements related to quality management and monitor changes, informing relevant peers. Support the implementation of process changes.
- Actively participate in the design, development and maintenance of the company’s documentation monitoring system.
- Active participation in internal, external and other audits according to the audit programme (preparation, implementation and conduct, identification and agreement of discrepancies with relevant areas, documentation – triggering audit report, monitoring effectiveness of actions)
- Coordinating the implementation of corrective/preventive actions, monitoring and verifying Ok analyses and actions.
- Preparation of MIR reports, preparation of field related statistics on the effectiveness of the functioning of the quality management system.
- Preparation of management reviews.
- Participation in MIR training courses and projects.
Expectations:
- Higher education
- Minimum 3 years’ experience in a similar field
- Knowledge of relevant standards (ISO 13485)
- Systematic approach, structured thinking.
- Internal auditor qualification an advantage
- Accurate, regular, reliable and independent work.
- Good communication and organisational skills.
- Flexibility, ability to work under pressure.
- Computer literacy (MS Office World, Excel, PowerPoint, SAP)
- Proficiency in written and spoken English.
An advantage:
- Qualifications as an internal auditor
- Knowledge of FDA 21 CFR Part820 standards
What we offer:
- Competitive salary, SZÉP card allowance after probationary period
- Full-time job
- Job security, possibility of long-term employment
- Performance-oriented motivation system
- International environment
How to apply:
send your CV in Hungarian and stating your salary requirements to toborzas@medres.hu