Key Responsibilities

• Manage the risk management system for our in vitro diagnostic medical devices, laboratory processes, and business continuity through profound analysis of process parameters and in-process controls

• Identify risks and risk mitigation measures in a cross-functional team

• Create and maintain risk management files for our globally offered in vitro diagnostic medical devices in accordance with ISO 14971

• Coordinate the system for nonconformities, CAPAs, and complaint handling with regard to risk management

• Provide input to further develop the quality management system in accordance with ISO 13485, ISO 15189, FDA QMSR, and IVDR (EU) 2017/746

• Degree in life sciences or another relevant scientific discipline

• Experience in risk management according to ISO 14971

• Good working knowledge of risk management methods (ISO 31000, FMEA, FTA); Six Sigma experience is a plus

• Working knowledge of quality management systems for medical device manufacturers and/or diagnostic laboratories is preferable

• Strong analytical mindset and structured approach

• Proactive, solution-oriented, and collaborative working style

• Business fluent in English; additional Spanish and/or German skills are advantageous

With employees from over 50 nations, CENTOGENE is a truly international company with offices is in Rostock, Berlin, Delhi, Boston, Valencia, Belgrade, and São Paulo.

We were born to help diagnostic patients with rare disease and today we evolved to help patients of all clinical specialties to make bold progress with guided solutions for physicians, their patients and pharma partners.