Job description
The QMS Specialist focuses on supporting the implementation and maintenance of the Quality Management System (QMS) according to ISO 13485 standards. This candidate will play an important role in ensuring compliance with regulatory requirements and contribute to improving quality processes in the production of medical devices.
- Supporting the maintenance and development of the QMS in accordance with ISO 13485 standards.
- Assisting in the preparation and organization of internal and external quality audits.
- Collaborating with other departments to identify and resolve quality issues.
- Managing records and documentation related to quality management processes.
- Supporting risk analysis and implementing CAPA (Corrective and Preventive Actions) measures.
- Assisting in training employees on QMS and regulatory requirements.
Requirements
- High school or university degree in a technical or healthcare-related field.
- A course or certification in ISO 13485 is an advantage but not mandatory.
- Experience in quality or production is an advantage.
- Basic knowledge of ISO 13485 and MDR regulatory requirements.
- Ability to work with documentation and solve problems with attention to detail.
- Basic analytical skills and willingness to learn new processes.
- Good communication and organizational skills.
- Proficiency in English at a communicative level.
We offer
- Opportunity to work in unique production facility.
- Career growth, professional education.
- Competitive and motivating salary.
- Nice and friendly working environment.
- Refreshments and kitchenette.
- Support of leisure time activities.
- 5 weeks of holidays and 3 days of personal leave.
- Other employee benefits.
Applications, containing CV, cover letter, contacts of references, and any other material a candidate considers relevant, should be sent to office@astrumlt.com.