Quality Affairs Specialist

Aortyx; Barcelona; Presencial; EUR 35.000 - 60.000; Jornada completa

Descripción de la vacante

Aortyx in Esplugues de Llobregat near Barcelona is seeking Jr. and Sr. Quality Affairs Specialists for full-time, on-site roles. You will contribute to the quality management system, ensuring regulatory compliance across product development and manufacturing.

Ideal candidates will have strong documentation control, audit preparation, CAPA leadership, risk management, and collaboration with cross-functional teams. Fluent Spanish and professional English (C1) are required.

Formación

• Bachelor’s degree in life sciences, engineering, or related field.
• Advanced degree in a relevant field is preferred.

Responsabilidades

• Maintain and develop the 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 internal and external audits, including Notified Body audits.
• Lead QMS projects, including audit schedules, records, and CAPA tracking.
• Support other areas from the quality assurance perspective.
• Assist daily activities of the quality department.

Conocimientos

QMS ISO13485

Audit preparation

CAPA management

Risk management

Documentation control

Quality reporting

Cross-functional collaboration

Analytical thinking

Communication skills

English proficiency

Educación

Bachelor's degree in life sciences/engineering

Advanced degree preferred

Descripción del empleo

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.