MedTech Quality Engineer: Validation, Risk & Compliance

BD; Zürich; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

BD in Switzerland seeks a Quality Engineer (m/w/d) to join a multidisciplinary team in Wangs. You will support validation, risk management, and quality assurance in a highly regulated medical device environment. You will bring hands-on experience with IQ/OQ/PQ, ISO 13485, EU MDR, and risk management (FMEA).

German and English fluency is mandatory to collaborate across functions and audits. The role offers exposure to global standards and opportunities to drive quality improvements across the

Qualifikationen

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

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and ISO 13485 / EU MDR
• Serve as quality subject matter expert during audits.
• Lead CAPA processes and drive continuous improvement.

Kenntnisse

Fluent in German and English

Analytical skills

Problem solving

Attention to detail

MS Office

DOE

Minitab

Collaborative mindset

Ausbildung

Bachelor's degree in engineering

Tools

MS Office

DOE

Minitab

Jobbeschreibung

BD in Switzerland seeks a Quality Engineer (m/w/d) to join a multidisciplinary team in Wangs. You will support validation, risk management, and quality assurance in a highly regulated medical device environment. You will bring hands-on experience with IQ/OQ/PQ, ISO 13485, EU MDR, and risk management (FMEA).

German and English fluency is mandatory to collaborate across functions and audits. The role offers exposure to global standards and opportunities to drive quality improvements across the