Quality Engineer: MedTech Validation & Compliance

Becton Dickinson; Vilters-Wangs; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

BD in Switzerland is seeking a Quality Engineer to drive compliance and robust validation in a highly regulated medical device environment. You will contribute to risk management, CAPA, and continuous improvement on cross‑functional teams in Wangs.

The role requires hands‑on IQ/OQ/PQ validation, knowledge of ISO 13485, ISO 14971/24971, and fluency in German and English. A strong analytical mindset and collaborative spirit are essential for success.

Qualifikationen

• Bachelor's degree in engineering.
• Experience in the medical device industry or a regulated environment.
• Knowledge of ISO 13485, ISO 14971/24971, EU MDR.
• Hands-on experience with IQ/OQ/PQ validation, statistical tools and CAPA.

Aufgaben

• Quality & Compliance: support all quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and applicable international standards (ISO 13485, EU MDR, ASTM).
• Serve as quality subject matter expert during regulatory and internal audits.
• Validation & Process Qualification: support validation and re‑validation of test methods and manufacturing processes.
• Develop, review, and approve protocols and reports for test method validation.
• Implement IQ, OQ and PQ process qualification activities, including protocol and report review.
• Risk Management: cross‑functionally collaborate on FMEAs (design, production, user).
• Create, maintain, and approve risk management documents in line with ISO 14971/24971.
• CAPA: lead root-cause analysis and corrective/preventive action implementation.
• Perform statistical analyses to determine process capability using Minitab and DOE.
• Support Manufacturing Engineering across quality-related tasks.

Kenntnisse

German language

English language

Quality engineering

Regulatory compliance

IQ/OQ/PQ validation

FMEA

Data analysis

Multidisciplinary collaboration

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

MS Office

Jobbeschreibung

BD in Switzerland is seeking a Quality Engineer to drive compliance and robust validation in a highly regulated medical device environment. You will contribute to risk management, CAPA, and continuous improvement on cross‑functional teams in Wangs.

The role requires hands‑on IQ/OQ/PQ validation, knowledge of ISO 13485, ISO 14971/24971, and fluency in German and English. A strong analytical mindset and collaborative spirit are essential for success.