Lausanne QA/QMS Lead – MedTech, ISO 13485

Dexterous Endoscopes; Lausanne; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Dexterous Endoscopes in Lausanne, Switzerland is seeking a QA/QMS Engineer to develop and maintain a robust quality management system in compliance with ISO 13485, FDA QSR, and international standards.

You will work with cross-functional teams to support design controls, risk management, verification and validation, and regulatory documentation throughout the product lifecycle.

Reporting to the CEO, you will help scale the quality function in a fast-growing medical device startup.

Qualifikationen

• 2+ years of quality engineering in MedTech.
• Fluent English (C1) required; additional languages a plus.
• Bachelor's or higher in Electrical or Mechanical Engineering.
• Experience with ISO 13485 and design controls.
• Familiarity with IEC 60601, IEC 62366, IEC 62304, ISO 14971.
• Experience with risk management, V&V, and DHF/technical/regulatory documentation.
• Experience with medical device testing, compliance, and certification.
• Experience in endoscopy or MedTech is a plus.

Aufgaben

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, and applicable international standards
• Ensure quality and regulatory compliance throughout the product lifecycle, including design controls, risk management, verification, and validation
• Lead and support the preparation of technical documentation for regulatory submissions
• Establish and manage testing protocols, validation plans, and quality procedures for product and system-level testing
• Collaborate with engineering teams to integrate quality processes into product development and ensure design compliance
• Support usability engineering, human factors, and system-level compliance activities, including electrical safety testing

Kenntnisse

Quality Engineering

English fluency

Electrical/Mechanical Eng

Regulatory knowledge

Ausbildung

Electrical or Mechanical Engineering

Jobbeschreibung

Dexterous Endoscopes in Lausanne, Switzerland is seeking a QA/QMS Engineer to develop and maintain a robust quality management system in compliance with ISO 13485, FDA QSR, and international standards.

You will work with cross-functional teams to support design controls, risk management, verification and validation, and regulatory documentation throughout the product lifecycle.

Reporting to the CEO, you will help scale the quality function in a fast-growing medical device startup.