Quality Manger

Quality Manger

Centogene

Rostock, Germany

Your Responsibilities

Your core responsibilities will include, but are not limited to:

• Support continuous improvement and maintenance of the QMS in compliance with:
  • ISO 13485;
  • ISO 15189;
  • Global regulatory requirements (e.g., MDSAP).
• Ensure compliance with international quality standards and regulatory requirements;
• Participation in regulatory inspections and external audits; support the planning and execution of internal audits;
• Manage and oversee:
  • Change control processes;
  • Non-conformities (NCs);
  • CAPA processes;
  • SCARs.
• Support with document control activities, including updates and maintenance in the eDMS;
• Perform Quality Control activities;
• Contribute to risk assessment processes.

Your profile

Education:

• Degree in life sciences or a related scientific discipline;
• Additional qualification in Quality Management is considered a plus.

Knowledge and Skills:

• Background in the life sciences sector; experience in the biotechnology or pharmaceutical industry will be highly valued;
• Proven experience with of ISO 15189, ISO 13485 and ISO14971 standards;
• Knowledge of MDR, IVDR, FDA QMSR;
• CLIA, CAP and GMP awareness is a plus;
• Strong understanding of quality methods and problem-solving tools (e.g., FMEA, 5 Whys, Ishikawa);
• Strong analytical, structured, and solution-oriented working style;
• Strong communication skills and confidence working with cross-functional teams;
• Ability to work in a structured, detail-oriented and compliant manner;
• Proficiency in Microsoft Word, Excel and electronic document management systems (eDMS);
• Fluent in English (written and spoken).