Quality Assurance Engineer (m/f/d)

Quality Assurance Engineer (m/f/d)

Location: Dreieich, Germany

What You Will Do

• Own and execute product release process for Custom Engineering Dreieich products, ensuring compliance with QMS, regulatory, and customer requirements.
• Maintain and harmonize Custom Engineering SOPs within the global QMS, coordinating cross‑functional reviews, change control activities, and 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, corrective action implementation, 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 MS Office tools (especially MS Excel) for analytics and data management.
• High attention to detail, strong coordination skills, and ability to work cross‑functionally with global QA & Engineering teams.
• Ability to communicate effectively in German and English (written and spoken).

Preferred Experience

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