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Quality Engineer (medical device)

About us

We are Salvia: an innovative startup active in the emerging field of bioelectronics. We derived the name Salvia from the Latin word salvere, which means to stay healthy. In addition, the Salvia-herb has been used to treat headaches and pain for centuries. Our mission is to give migraineurs back their life. Salvia is ambitious: we want to provide drug-free solutions that are effective and inherently side-effect free and make our novel solutions widely accessible.

The challenge

We offer a challenging position for an experienced Quality Engineer in medical devices. Working together with our system architect, Salvia R&D team and our external technology partners, you will be involved in medical device compliance activities throughout the whole life cycle of our active implantable medical device system to bring safe, reliable, and high-quality medical devices to the EU and US markets. Closely collaborating with Salvia’s multidisciplinary team, you take ownership and have a pragmatic approach. You enjoy working in a scale-up environment and have a can-do attitude. You realize that quality is of paramount importance, and you are passionate about delivering solutions that truly stand out.

Responsibilities

• Ensuring that Salvia’s design and development procedures are followed in the R&D projects.
• Maintaining compliance with applicable standards and regulations.
• Playing an active role in defining and conducting quality checks to verify that products meet quality standards as part of the team.
• Reviewing documentation to ensure good documentation practice and QMS compliance.
• Contributing to root cause analyses of quality issues, developing corrective actions to prevent reoccurrence.
• Collaborating with procurement to establish quality requirements/control for external suppliers.
• Support design transfer activities to manufacturing.

Your Profile

• Experienced in quality engineering in a production or product development environment (preferably medical devices, pharma).
• Familiar with relevant regulations and standards (e.g. EU MDR, FDA, ISO 13485, IEC 62304, IEC 60601).
• Strong verbal and writing skills in English.
• Strong analytical mind and approach challenges from a practical standpoint.
• Proactively defines work and identifies improvement activities in line with quality and business needs.
• Bachelor’s or master’s degree in (Bio)Medical Engineering, Electrical Engineering, or equivalent.

Contact

mb.info@salvianeuro.com