As a Senior Quality Assurance Specialist , you will play a key role in ensuring compliance with quality and regulatory requirements for both our current and future product portfolio. Initially, your primary focus will be on our flagship product, JULÄINE, a Class III injectable medical device.
In this role, you will collaborate closely with cross-functional teams, including the broader Quality Assurance and Regulatory Affairs teams, as well as stakeholders in Manufacturing, Commercial, Clinical Affairs, and Research & Development. Together, you will drive the preparation and submission of quality documentation to meet regulatory standards and support product approvals across multiple regions.
You will report directly to the Senior QA Manager.
You will join our global Quality Assurance team, with colleagues based across several European countries. The team plays a critical role in the company’s success, working collaboratively to ensure the highest quality standards. Support the development, maintenance,



and continuous improvement of the QMS in accordance with applicable regulatory requirements and standards (including ISO 13485, MDR, MDSAP).
Ensure quality processes are effectively established, monitored, and continuously improved across the organization.
Drive the creation, review and harmonization of quality procedures, work instructions, and quality documentation.
Oversee change control activities, ensuring appropriate quality assessment, implementation, and effectiveness verification.
Regulatory Affairs, Operations, R&D;) to ensure quality objectives are achieved. Contribute to inspection readiness and support interactions with certification bodies and regulatory authorities.
Monitor and analyse QMS performance through quality metrics.
Prepare, consolidate, and maintain quality inputs to support management review activities, ensuring timely availability of performance and compliance data.
Generate periodic quality reports and trending analyses to support managemen

📌 Quality Assurance Specialist (Italia)
🏢 Nordberg Medical
📍 Italia