MedTech Quality Engineer - Validation, Risk & Compliance

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

Zusammenfassung

BD in Wangs, Switzerland, is seeking a Quality Engineer (m/w/d) to join a regulated medical device manufacturing team focused on validation, risk management, and quality assurance activities.

You will apply IQ/OQ/PQ, FMEA, ISO 13485, and EU MDR knowledge; collaborate with cross-functional teams; support audits and CAPA; and bring fluent German and English to ensure rigorous quality standards.

Qualifikationen

• Bachelor’s degree in an engineering discipline (preferably Mechanical, Processing, Materials, Chemical or Pharmaceutical Engineering).
• Experience in the medical device industry or a regulated environment.
• Hands-on validation experience (IQ/OQ/PQ), statistical tools and CAPA processes.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, ISO 13485 and EU MDR.
• Serve as quality SME during regulatory and internal audits.

Kenntnisse

Quality Assurance

GxP & Regulatory

IQ/OQ/PQ

FMEA

ISO 13485

EU MDR

German & English

Risk Management

Analytical Skills

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

Jobbeschreibung

BD in Wangs, Switzerland, is seeking a Quality Engineer (m/w/d) to join a regulated medical device manufacturing team focused on validation, risk management, and quality assurance activities.

You will apply IQ/OQ/PQ, FMEA, ISO 13485, and EU MDR knowledge; collaborate with cross-functional teams; support audits and CAPA; and bring fluent German and English to ensure rigorous quality standards.