Quality Engineer – Validation, FMEA & Regulatory Compliance

About the role

Join a global medical technology leader as a Quality Engineer supporting validation, risk management and quality assurance in a highly regulated medical device manufacturing environment.

Key responsibilities

• Support validation and re‑validation of test methods and manufacturing processes, including IQ, OQ and PQ activities.
• Develop, review and approve protocols and reports for test method validation.
• Ensure compliance with internal procedures, FDA regulations and international standards (ISO 13485, EU MDR, ASTM).
• Serve as quality subject‑matter expert during regulatory and internal audits.
• Collaborate on FMEAs (design, production, user) and maintain risk management documents per ISO 14971/24971.
• Lead CAPA processes, perform root‑cause analysis and implement corrective/preventive actions.
• Conduct statistical analyses of process capability using Minitab and Design of Experiments.

Required profile

• Bachelor's degree in Mechanical, Process, Materials Science, Chemical or Pharmaceutical Engineering.
• Experience in the medical device industry or a comparable regulated environment.
• Fluent in German and English (written and spoken).

Required skills

• Knowledge of ISO 13485, ISO 14971, EU MDR.
• Hands‑on experience with IQ/OQ/PQ validation activities.
• Proficiency with Minitab and DOE statistical tools.
• Advanced MS Office skills, especially Word.