✨ The Role in One Sentence

ten23 health is seeking a Quality Systems Expert to support the build-up and operational readiness of the Quality Management System for new device assembly capabilities.

📋 What You'll Likely Do

• 30%: Lead the roll-out and integration of the QMS for new device assembly operations, ensuring alignment with business and compliance needs.

• 30%: Own and optimize core quality system processes (deviations, CAPAs, change control, training, documentation) with a dedicated focus on device assembly.

• 40%: Lead preparation and coordination of audits and inspections, especially during ramp-up and launch of new device-related operations.

🧑‍💻 Profiles Doing This Job

• High Priority: Master’s degree in Life Sciences, Engineering, or a related scientific/technical discipline.

• High Priority: Minimum 4 years’ experience in quality systems within pharmaceutical or medical device manufacturing.

• High Priority: Hands-on experience with eQMS platforms (e.g., TrackWise).

📈 How This Role Will Look on Your CV

• Led the implementation and optimization of quality systems in a device assembly environment.