Medical Device Quality Engineer: Validation & Regulatory

Jobtailor; Vilters-Wangs; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Quality Development Engineer in the Swiss canton of St. Gallen to support commercial production quality activities.

You will ensure compliance with ISO 13485, EU MDR, FDA regulations, and participate in audits, validation, CAPA, and risk management using Minitab and DOE. Fluent German and English are mandatory, and collaboration across multidisciplinary teams is essential.

Qualifikationen

• Bachelor's degree in an engineering discipline; Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Eng preferred.
• Experience in the medical device industry or regulated environment.
• Knowledge of ISO 13485, ISO 14971/24971, EU MDR.
• Hands-on validation activities (IQ/OQ/PQ), statistical tools, and CAPA processes.

Aufgaben

• Support all 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 validation (IQ/OQ/PQ) and CAPA processes.
• Perform statistical analyses using Minitab and DOE to determine process capability.

Kenntnisse

Fluent German

Fluent English

Analytical skills

Problem-solving

Process-oriented

Attention to detail

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

MS Office (Word)

Jobbeschreibung

Jobtailor is seeking a Quality Development Engineer in the Swiss canton of St. Gallen to support commercial production quality activities.

You will ensure compliance with ISO 13485, EU MDR, FDA regulations, and participate in audits, validation, CAPA, and risk management using Minitab and DOE. Fluent German and English are mandatory, and collaboration across multidisciplinary teams is essential.