Quality Engineer, Medical Devices – Validation & Risk

Becton Dickinson

Vilters-Wangs

Vor Ort

CHF 97.000 - 147.000

Vollzeit

Vor 7 Tagen

Sei unter den ersten Bewerbenden

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Zusammenfassung

Becton, Dickinson, and Company in Wangs, Switzerland is seeking a Quality Engineer (m/w/d) for Validation & Risk Management in the medical devices sector. You will support quality development activities, ensure compliance with ISO 13485, ISO 14971, and MDR, participate in FMEAs and risk management, and drive CAPAs with cross-functional teams.

Fluent German and English are mandatory. This role emphasizes validation, data analysis with Minitab, and applying robust quality systems in a global

Qualifikationen

Bachelor's degree in an engineering discipline with relevance to medical devices.
Solid knowledge of ISO 13485, ISO 14971/24971 and MDR requirements.
At least 3 years in medical devices or a regulated environment.

Aufgaben

Support quality development activities for commercial production.
Ensure compliance with quality systems and applicable standards.
Collaborate on FMEAs and risk management documents.
Assist with validation/re-validation of tests and processes.
Develop and approve validation protocols and reports.
Contribute to CAPAs and root-cause analyses.
Support regulatory audits as quality expert.

Kenntnisse

Fluent German

Fluent English

Analytical skills

DOE knowledge

Minitab

Regulatory knowledge

Quality systems

MS Office

Multidisciplinary teamwork

Process validation

Ausbildung

Bachelor's degree in engineering

Tools