✨ The Role in One Sentence

ten23 health is seeking a Senior Qualification Engineer to establish and qualify new device assembly capabilities for combination products within a GMP-regulated environment.

📋 What You'll Likely Do

• 30%: Lead the planning, execution, and documentation of qualification activities for new device assembly equipment, infrastructure, and supporting systems.

• 30%: Collaborate with the device assembly project team to define qualification strategies aligned with device-specific regulatory requirements.

• 40%: Provide expert input during deviation investigations, change controls, and process-related troubleshooting in qualification scope.

🧑‍💻 Profiles Doing This Job

• High Priority: Degree in engineering or a technical/scientific discipline.

• High Priority: Minimum 5 years of experience in qualification within a GMP-regulated or medical device environment.

• High Priority: Familiar with combination product regulations (e.g. EU MDR, FDA 21 CFR Part 4/820).

📈 How This Role Will Look on Your CV

• Led qualification activities for new device assembly equipment in a GMP-regulated environment.