Quality Engineer, Medical Devices — Validation & Risk

BD; Österreich; Vor Ort; EUR 103.000 - 157.000; Vollzeit

Zusammenfassung

BD in Switzerland is seeking a Quality Engineer (m/w/d) for medical devices, focusing on validation and risk management. You will establish quality systems, develop test protocols, and support CAPAs in a multidisciplinary, international team.

The role requires: a Bachelor’s degree in engineering, at least 3 years in medical devices, fluent German and English, and strong analytical skills. Knowledge of ISO 13485 and MDR is beneficial.

Qualifikationen

• Bachelor’s degree in engineering (mechanical/process/materials/chemical/pharmaceutical).
• Practical knowledge of global regulations for medical devices (ISO 13485, ISO 14971/24971, EU MDR).
• At least 3 years in the medical device industry or similar regulated environment.
• Fluent German and English (written and spoken)
• Strong analytical skills and high accuracy
• Ability to work in a multidisciplinary, international team
• Proficient in MS Word
• Knowledge of DOE and Minitab.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality system requirements (internal procedures, FDA/ISO standards).
• Collaborate with Manufacturing Engineering on FMEAs and risk management documents.
• Support validation and re-validation of test methods and processes.
• Develop, review and approve validation protocols/reports.
• Assist with CAPAs and root-cause analyses.
• Perform statistical analyses to determine process capability.
• Contribute to process qualification/validation activities (IQ/OQ/PQ).
• Participate in regulatory audits as a quality expert.

Kenntnisse

Fluent German

Fluent English

Analytical skills

Process-oriented

Team collaboration

MS Office

DOE

Minitab

Ausbildung

Bachelor’s degree in an engineering discipline

Tools

Minitab

DOE

MS Office

Jobbeschreibung

BD in Switzerland is seeking a Quality Engineer (m/w/d) for medical devices, focusing on validation and risk management. You will establish quality systems, develop test protocols, and support CAPAs in a multidisciplinary, international team.

The role requires: a Bachelor’s degree in engineering, at least 3 years in medical devices, fluent German and English, and strong analytical skills. Knowledge of ISO 13485 and MDR is beneficial.