To support further development of our Quality management department at our global headquarters in Garching, Munich, we are looking for a Junior Quality Engineer to join a team committed to providing innovative solutions to a global community of healthcare professionals and their patients.
- Lead and manage Corrective and Preventive Action (CAPA), change management, compliance activities to continuously improve the quality management system as per ISO 13485.
- Support in external & internal audits, including tracking and follow-up on all audit findings.
- Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP) and technical documentation as per MDD & MDR.
- Interact with internal stakeholders to establish and implement quality processes and streamline supply chain management.
- Support in risk management activities using tools such as FMEA, root cause analysis and risk mitigation measures as per ISO 14971.
- Evaluate and assess supplier management system, supplier communication and support in critical supplier audits as per ISO 13485.
- Supervise testing and validation of medical devices to comply with applicable international standards.
- Execute training where necessary for various SOPs and working instructions implemented in the QMS.
Requirements and skills
- University degree in Mechanical/Production/Biomedical Engineering or related field.
- 1-2 years of experience in the field of quality management or regulatory environment.
- Knowledge of ISO 13485 or ISO 9001 is preferred.
- Knowledge of MS office applications (especially outlook, excel, word) is essential.
- Fluent in English (C1) and German (B2).
- A team player, highly motivated and independent personality would be preferred
- A responsible position in a highly motivated team
- Growing with a fast-pacing company
- Personal career development into a leading position within the company
- A great working environment
- The opportunity to actively shape OncoBeta’ s success
Sound like the right job for you?
If you would like to join the OncoBeta® team, please send us your CV with your earliest entry date as well as your salary expectations to [email protected]