Aortyx is looking for Jr. and Sr.

Quality Affairs

Specialists (m/f) to work full-time, on-site, in Esplugues de Llobregat, Barcelona.

Main tasks and responsibilities

- Assist in the maintenance and continuous development of the quality management system (QMS) according to ISO 13485 and FDA requirements.

- Author, review, and monitor new and existing QMS procedures and processes.

- Interact with external quality affairs consultants and testing laboratories.

- Support all internal and external audits, including preparation and execution of Notified Body audits.

- Lead QMS projects, including creating and maintaining internal audit schedules and records, and tracking CAPA activities as required.

- Support other areas from the quality assurance perspective.

- Support the daily activities of the quality department.

The role involves supporting, maintaining, and improving the company’s quality management system in alignment with regulatory and industry standards. Day-to-day activities include drafting, reviewing, and updating quality procedures and documentation; coordinating internal audits and follow-up actions; and supporting risk management and corrective/preventive actions.



The role also involves collaborating with cross-functional teams to ensure quality requirements are integrated into product development and manufacturing as well as preparing and maintaining records needed for regulatory submissions and inspections.

Qualifications

EDUCATION

- Bachelor's degree in life sciences, engineering, or a related field.

- Advanced degree (e.g., Master's, PhD) is preferred.

SKILLS

- Strong knowledge of quality management systems and applicable regulations or standards (e.g., ISO 13485), with experience implementing and maintaining quality frameworks in a regulated environment.

- Proficiency in documentation control, audit preparation, and quality reporting, including the ability to create, review, and manage procedures, work instructions, and records with high attention to detail.

- Experience in risk management, root-cause analysis, and corrective and preventive actions (CAPA), with the ability to use structured problem-solving methods.

- Effective collaboration skills for working with engineering, operations, regulatory affairs, and other teams to align quality activities with business and product goals.

- Strong analytical and organizational skills, including the ability to prioritize tasks, meet deadlines, and manage multiple projects in a fast-paced environment.

- Excellent communication and interpersonal skills.

- Analytical thinking and problem-solving abilities.

- Fluent Spanish and Professional English (C1) are required.

📌 Quality Affairs Specialist (Barcelona)
🏢 Aortyx
📍 Barcelona