Complaints Specialist

Grifols, S.A; Parets del Vallès; Presencial; EUR 42.000 - 54.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible schedule

Occasionally remote

Descripción de la vacante

Grifols S.A. is seeking a Specialist to manage customer complaints for immunohematology products and oversee post-market surveillance in the Diagnostic Business Unit.

You will analyze complaints, perform risk assessments, create trend reports, and coordinate with Health Authorities on reportability and recalls, contributing to the quality system and regulatory compliance within a global healthcare leader. The role requires a degree in engineering, 2 years in QA or regulatory affairs, and English

Formación

• Bachelor's Degree in Engineering (Industrial or Organizational).
• 2 years of experience in Complaints, Quality Assurance or Regulatory Affairs within pharmaceutical industry or medical devices.
• Experience with data automation and AI tools is a plus.

Responsabilidades

• Manage complaints related with Software and Hardware in immunohematology products.
• Analyze complaints with risk assessment and health authority reportability.
• Create trend reports, complaints monitoring, and auditing of cases.
• Reportability of adverse events to Health Authorities and involvement in recalls and field actions.
• Develop and maintain quality procedures for complaints, vigilance and post-market surveillance.
• Create post-market surveillance plans and reports per regulations.

Conocimientos

Quality Assurance

Regulatory Affairs

English (C1)

Teamwork

Educación

Bachelor's Degree in Engineering (Industrial, Organizational)

Herramientas

AI tools

Data automation tools

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.

In our Technical Area Department, we are looking for a Specialist to manage customer complaints for all immunohematology products of the Diagnostic Business Unit, as well as the management of the post-market surveillance system of Diagnostic Grifols SA.

What your responsibilities will be

• Manage complaints related with Software and Hardware, as part of immunohematology products.
• Analyze complaints by performing risk assessment and reportability assessment to Health Authorities.
• Create trend reports, complaints monitoring, and auditing registered cases.
• Reportability of adverse events to Health Authorities and participation in product recalls, defining Field Safety Corrective Actions and Field Safety Notices according to applicable regulations.
• Participate in the development and maintenance of quality procedures related to complaints, vigilance system and post-market surveillance.
• Create post-market surveillance plans and reports according to applicable regulations.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor's Degree in Engineering (Industrial, Organizational).
• 2 years of experience in Complaints, Quality Assurance or Regulatory Affairs within pharmaceutical industry and/or medical devices.

Experience in data automation and Artificial Intelligence tools is a plus.

• English level is C1.
• Analytical and precision skills.
• Ability to work in a team.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available atwww.grifols.com .

We believe in diverse talent and want to remove any barriers that may hinder your participation.

Grifols is an equal opportunity employer.

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h(with the same flexible start time).

Benefits package

Contract of Employment: Permanent

Flexibility for U Program: Occasionally remote