Quality Engineer

Volumina Medical seeks a Quality Engineer in Epalinges to manage QMS compliance and assurance for Class III medical devices, supporting R&D and supplier quality.

This position serves as a key component of the Quality function, bridging R&D activities with the maintenance of the Quality Management System for Class III medical devices. Reporting to the Global Head of Quality and Regulatory Affairs, the engineer ensures that quality standards are embedded throughout the product lifecycle and operational processes.

Responsibilities

• Develop, implement, and monitor the QMS in alignment with ISO 13485, 21 CFR Part 820, and MDR 2017/745.
• Oversee Quality Assurance activities across teams to guarantee strict adherence to established procedures.
• Review and approve quality documentation, including QC records, incoming inspections, and training logs.
• Lead Change Control and Non-Conformity processes, coordinating follow-up actions with relevant teams.
• Collect, analyze, and report Quality KPIs to drive continuous improvement of the QMS.
• Support risk management activities and assist teams in identifying, qualifying, and evaluating suppliers.
• Ensure annual supplier assessments are completed per the Quality Plan and review Quality Agreements as needed.
• Manage supplier orders and act as the primary Quality contact for all company suppliers.
• Prepare and follow internal and supplier audit plans, participating in their execution.
• Contribute to Notified Body audits as a Quality Subject Matter Expert.
• Maintain the Design History File (DHF), ensuring traceability and consistency through development phases.
• Support Design Verification activities, such as drafting protocols/reports and handling deviations.
• Manage testing activities with qualified subcontractors, including sample preparation and shipping.
• Oversee stability studies, including data collection, analysis, and report drafting.
• Train teams on QMS requirements to foster a sustainable quality culture.
• Report deviations and non-conformities to the Quality Management Representative.
• Provide solution-oriented QA support and assist teams in writing and reviewing technical documents.

Requirements

• Engineering degree or Bachelor/Master in Sciences and/or Quality Assurance/Regulatory Affairs.
• Minimum 3-5 years of experience in Quality Assurance within Pharma, Biotech, or Medical Device industries.
• Strong knowledge of medical device regulations (e.g., 21 CFR, MDR 2017/745) and standards (e.g., ISO 13485, ISO 14971).
• Proven experience in contributing to QMS development and maintenance.
• Good understanding of the medical device development process (Design Control).
• Ability to critically analyze and provide feedback on technical and quality documentation.
• Fluent oral and written proficiency in English.

What the company offers

• A dynamic and stimulating work environment at the cutting edge of biomedical technology innovation.
• The opportunity to express talents and grow with the team.
• Integration into an interactive team where ideas are encouraged.
• The chance to contribute to improving the lives of millions of patients.

About the company

Volumina Medical is a start-up spin-off of EPFL, active in the field of medical devices for plastic and reconstructive surgery. The company focuses on breakthrough innovations aimed at regenerating soft parts of the human body damaged by aging, tumor excision, genetic malformations, or trauma.

• The company is a start-up spin-off of EPFL.
• The company develops breakthrough innovations for plastic and reconstructive surgery.
• The company targets the regeneration of soft parts of the human body damaged due to ageing, tumor excision, genetic malformation, or trauma.