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.

About The Team

You will join our general 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. We foster an entrepreneurial and team-oriented culture,



where you will have the opportunity to deepen your expertise, broaden your experience, and contribute to expanding our presence into new markets and product areas.

Key Responsibilities

Your responsibilities will include, but not be limited to:

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.
Support and maintain traceability processes to ensure compliance throughout product lifecycle activities.
Coordinate CAPA processes and ensure timely investigation, i

📌 Senior Quality Assurance Specialist (Madrid)
🏢 Nordberg Medical
📍 Madrid