Key Responsibilities

• Implement and maintain a quality management system compliant with ISO 13485, ISO 15189, and other global regulatory requirements (e.g., MDSAP), including:

• Supplier management

• Event handling

• Management review

• Implement and maintain an environmental management system according to ISO 14001

• Supervise maintenance of the information security management system according to ISO 27001

• Guide internal stakeholders in implementing QMS requirements

• Support design & development teams of CE-marked and in-house in vitro diagnostic medical devices

• Manage internal and external audits by accrediting bodies and clients, as well as supplier audits, including:

• Audit lead

• Resolution of audit findings

• Act as deputy for the Head of Department as PRRC according to §15 IVDR and as Medical Device Safety Officer according to §6 of the German Medical Device Operator Ordinance

• Proven track record in implementation and maintenance of quality management systems according to ISO 13485 or ISO 15189

• Good working knowledge of MDR, IVDR, and FDA QMSR

• Willingness to travel for affiliate visits and supplier audits

• Degree in life sciences or another relevant scientific discipline

• 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.