Quality Engineer, Medical Devices – Validation & Risk Mgmt

BD; Vilters-Wangs; Vor Ort; CHF 97.000 - 147.000; Vollzeit

Zusammenfassung

BD in Wangs, Switzerland is seeking a Quality Engineer (m/w/d) in medical devices focused on validation and risk management. The role requires conducting quality development activities, ensuring compliance with ISO and MDR standards, and collaborating with cross-functional teams including Manufacturing Engineering.

The ideal candidate has a engineering degree, 3+ years in regulated environments, and fluent English and German.

Qualifikationen

• Bachelor's degree in an engineering discipline.
• 3+ years in medical device or regulated environment.
• Fluent English and German, written and spoken.
• Knowledge of ISO 13485, ISO 14971/24971 and EU MDR.
• Experience with quality systems and regulatory requirements.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality system requirements and standards.
• Collaborate with Manufacturing Engineering on FMEAs and risk documents.
• Assist validation and qualification of test methods and processes.
• Support CAPAs and root-cause analyses.
• Act as quality expert in regulatory audits.

Kenntnisse

Analytical skills

German & English fluency

Process orientation

Team collaboration

MS Office

DOE

Minitab

Regulatory knowledge

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

MS Word

Jobbeschreibung

BD in Wangs, Switzerland is seeking a Quality Engineer (m/w/d) in medical devices focused on validation and risk management. The role requires conducting quality development activities, ensuring compliance with ISO and MDR standards, and collaborating with cross-functional teams including Manufacturing Engineering.

The ideal candidate has a engineering degree, 3+ years in regulated environments, and fluent English and German.