Quality Manger (Rostock)

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

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)

What we offer

· Exciting International and diverse team which stands for integrity, involvement and innovation within the life sciences sector

· Training & development opportunities

· Company benefits such as company health insurance and company discounts

· Primarily on-site role with some remote work flexibility

· Permanent contract

About us

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.

Our Values

We Care: A culture of empathy and understanding for each other, our customers, and our patients, constantly driving our mission forward

We Innovate: A culture of big ideas, being bold, and taking calculated risks to develop never-before-seen solutions

We Act With Integrity: A culture of keeping to our principles with self-awareness, intellectual honesty, and speaking up

If you are interested, we look forward to receiving your application, including your CV, motivation letter, earliest possible start date, and salary expectations.