Quality Engineer, Medical Devices — Validation & Risk

BD; Vilters-Wangs; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

BD is seeking a Quality Engineer (m/w/d) in Wangs, Switzerland, focused on validation and risk management for medical devices. You will work across the organization to ensure quality standards are met and processes are robust.

Responsibilities include managing FMEAs, validating test methods, and supporting CAPAs, with fluency in English and German. The role requires a engineering degree and 3+ years in a regulated medical device environment, based at BD in Switzerland.

Qualifikationen

• Bachelor's degree in engineering; disciplines include mechanical, process, materials science, chemical or pharmaceutical engineering.
• Fluent English and German (written and spoken) is mandatory.
• 3+ years in medical devices or a similarly regulated environment with knowledge of regulatory requirements and quality systems.
• Knowledge of ISO 13485, ISO 14971/24971 and MDR is required.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality system requirements defined by procedures, FDA, and ISO/MDR/ASTM.
• Collaborate with Manufacturing Eng. on FMEAs and risk management documents.
• Assist in validation/re-validation of test methods and processes.
• Develop, review and approve validation protocols and reports for test methods.
• Support with CAPAs and root-cause analyses.
• Act as expert in quality functions during regulatory audits.

Kenntnisse

Fluent German and English

Analytical skills

Process-oriented

Multidisciplinary teamwork

Ausbildung

Bachelor's degree in engineering

Tools

MS Office (Word)

Minitab

Jobbeschreibung

BD is seeking a Quality Engineer (m/w/d) in Wangs, Switzerland, focused on validation and risk management for medical devices. You will work across the organization to ensure quality standards are met and processes are robust.

Responsibilities include managing FMEAs, validating test methods, and supporting CAPAs, with fluency in English and German. The role requires a engineering degree and 3+ years in a regulated medical device environment, based at BD in Switzerland.