QA/QMS Engineer

The company seeks a Mid-level QA/QMS Engineer in Lausanne to build and maintain a compliant Quality Management System for medical devices, reporting directly to the CEO.

This position is responsible for establishing and sustaining a robust Quality Management System that adheres to ISO 13485, FDA regulations, and other international standards. The engineer ensures that medical devices satisfy all regulatory and quality mandates across their entire lifecycle, while receiving guidance from an advisory board of seasoned experts.

Responsibilities

• Create, execute, and upkeep a Quality Management System aligned with ISO 13485 and relevant global standards.
• Guarantee quality and regulatory adherence during every phase of the product lifecycle, covering design controls, risk management, verification, and validation.
• Lead and assist in compiling technical documentation required for regulatory submissions.
• Define and oversee testing protocols, validation plans, and quality procedures for product and system-level evaluations.
• Partner with engineering teams to embed quality processes into product development and verify design compliance.
• Assist with usability engineering, human factors, and system-level compliance tasks, including electrical safety testing.

Requirements

• Minimum of two years in Quality Engineering within the MedTech sector.
• Fluent English proficiency at the C1 level.
• A degree in Electrical or Mechanical Engineering, with a preference for an electrical focus or relevant experience.
• Hands-on experience with ISO 13485 and design control requirements.
• Background in risk management, verification & validation, and technical/regulatory documentation (e.g., DHF).
• Knowledge of standards like IEC 60601, IEC 62366, IEC 62304, and ISO 14971.
• Experience with medical device testing, compliance, and certification processes.

Nice to have

• Proficiency in additional languages is advantageous.
• Prior experience in endoscopy or comparable MedTech firms is beneficial.