QA Manager

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

Location: Lausanne, Switzerland

Employment Type: 100%

Location Type: Fully on-site

At Dexterous Endoscopes, we’re building a new generation of endoscopes connected to a standardized tablet platform, designed to make minimally invasive procedures safer, faster, and more precise. Our technology helps surgeons access challenging anatomy and perform treatments with greater stability and control.

As an EPFL spin-off, we are a fast-growing medical device startup developing breakthrough endoscopy solutions and preparing our first products for regulatory approval. This is a great opportunity for people who enjoy working in a high-potential startup environment, where you can have a direct impact on the product and grow with the company.

About The Role

This QA/QMS Engineer role focuses on developing and maintaining a robust Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and applicable international standards. You will play a key role in ensuring that our medical devices meet regulatory and quality requirements throughout the product lifecycle.

Working closely with cross-functional teams, you will support design controls, risk management, verification & validation, and regulatory documentation in line with 21 CFR 820 / FDA QSR. You will also help establish testing protocols, validation plans, and quality procedures, while contributing to system testing, electrical safety, and usability engineering activities.

You will report directly to the CEO and work with guidance from experienced regulatory and quality experts on our advisory board, providing strong support as you build and scale the quality function.

This role is suited for engineers who are comfortable operating in a regulated environment and taking ownership of quality processes. In an early-stage medical technology startup, you will need initiative and attention to detail to build and improve systems from the ground up. If you are motivated to ensure that innovative medical technology meets the highest standards of safety and compliance, this role offers that opportunity.

Responsibilities

• 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

Required Knowledge And Experience

• 2+ years of experience in Quality Engineering within the medical device (MedTech) industry
• Fluent in English (C1); additional languages are a plus
• Degree in Electrical or Mechanical Engineering (electrical focus or experience preferred)
• Experience with ISO 13485 and design control requirements
• Experience with risk management, verification & validation, and technical/regulatory documentation (e.g., DHF)
• Familiarity with relevant standards such as IEC 60601, IEC 62366, IEC 62304, and ISO 14971
• Experience with medical device testing, compliance, and certification processes
• Experience from endoscopy or similar MedTech companies is a plus

Dexterous Endoscopes is an equal opportunity employer. We welcome applications from candidates of all backgrounds and are committed to building an inclusive and diverse team.