Quality Assurance Engineer (m/f/d)

Quality Assurance Engineer (m/f/d)

Responsible for maintaining and improving the Quality Management System by ensuring Cytiva, Customer, and Regulatory requirements are met through project execution and delivery of product.

Reports to the Site Quality Manager and is part of the Custom Engineering Quality Assurance department located in Dreieich; the role is on‑site.

What you will do:

• Own and execute the product release process for Custom Engineering Dreieich products, ensuring compliance with QMS, regulatory, and customer requirements.
• Own, maintain, and harmonize Custom Engineering SOPs within the global QMS. Coordinate cross‑functional reviews, change control activities, and related training to ensure global implementation and compliance.
• Manage customer complaints, including timely assessment, documentation, response, and trend analysis.
• Manage Deviations and CAPAs in QMS, ensuring effective root cause analysis, implementation of corrective actions, and timely closure.

Who you are:

• Bachelor’s degree in engineering or science discipline.
• Minimum 2‑3 years of experience in a Quality role, preferably in the Life Sciences industry.
• Good knowledge of using MS Office tools such as MS Excel to perform analytics and data management.
• High attention to detail, good coordination skills, and ability to work cross‑functionally with global QA & Engineering teams.
• Ability to communicate effectively in both German and English (written and spoken).

It would be a plus if you also possess previous experience in:

• Knowledge and awareness of the methods and techniques of Quality Control in the manufacturing industry.
• Technical knowledge of systems/devices used in the biopharma field.
• ISO 9001.