Quality Engineer, Medical Devices: Validation & Risk Mgmt

BD; Zürich; Vor Ort; CHF 97.000 - 147.000; Vollzeit

Zusammenfassung

BD is seeking a Quality Engineer (m/w/d) for Validation & Risk Management in Wangs, Switzerland. The role focuses on establishing quality control systems, setting product requirements, and identifying defects within a global medtech context.

The successful candidate will drive FMEAs, risk management, and method validation, collaborating across cross-functional teams to ensure ISO 13485 and MDR compliance. Fluency in German and English, plus an engineering degree, are mandatory.

Qualifikationen

• Bachelor's degree in engineering, preferably mechanical or process engineering, materials science, chemical or pharmaceutical engineering
• Practical knowledge of global regulations and standards for medical devices (ISO 13485, ISO 14971/24971, MDR)
• At least 3 years in medical devices or similar regulated environment with knowledge of regulatory requirements and quality systems
• Fluent German and English with written skills (mandatory)
• Good analytical skills
• Process-oriented with high accuracy
• Ability to work in multidisciplinary and international teams
• Knowledge of MS Office (Word)
• Knowledge of Design of Experiment (DOE) and Minitab software

Aufgaben

• Support quality development activities for commercial production
• Ensure compliance with quality system requirements (ISO, MDR, FDA where applicable)
• Collaborate with Manufacturing Engineering on FMEAs and risk management documents
• Support validation/re-validation of test methods and processes
• Develop, review and approve validation protocols and reports
• Assist Manufacturing Engineering with quality-related tasks
• Carry out statistical analyses to assess process capability
• Support IQ/OQ/PQ activities and protocol/report reviews
• Contribute to CAPAs and root-cause analyses
• Act as quality expert in regulatory audits

Kenntnisse

German language

English language

Analytical skills

Process orientation

Multidisciplinary teamwork

MS Office

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

Jobbeschreibung

BD is seeking a Quality Engineer (m/w/d) for Validation & Risk Management in Wangs, Switzerland. The role focuses on establishing quality control systems, setting product requirements, and identifying defects within a global medtech context.

The successful candidate will drive FMEAs, risk management, and method validation, collaborating across cross-functional teams to ensure ISO 13485 and MDR compliance. Fluency in German and English, plus an engineering degree, are mandatory.