Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. JOB SUMMARY Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. KEY ACCOUNTABILITIES Collaborate in maintaining the quality system documentation processes and procedures adopted by the company. Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence. Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.



Support the regulatory submissions for market authorization for medical device products. Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures. Facilitate the approval process for software releases. Disseminating knowledge about the Quality System and regulatory requirements. Review Promotional and advertising materials. Oversee post-market surveillance activities related to medical device products. Offer guidance and mentorship to QARA team members at lower leve ls NETWORKING / KEY RELATIONSHIPS The main relationships within to the Werfen Group are: QARA Manger, QA Leads, Validation Led Factory Lead and Solution Leaders Customer Application Lifecycle manager (ALM) Notified Bodies and Competent Authorities for product regulatory compliance. This position may also require cooperating with other companies inside Werfen. MINIMUM KNOWLEDGE & EXPERIENCE REQUIRED FOR THE POSITION Education:

📌 Senior QARA Specialist (Cataluña)
🏢 Actual Talent
📍 Cataluña