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Junior Quality Engineer

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.

Job Description:

  • 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

We offer:

  • 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]