Immunohematology Complaints & Post-Market Specialist

Grifols, S.A; Parets del Vallès; Sur place; EUR 42 000 - 54 000; Plein temps

Avantages offerts par ce poste

Flexible schedule

Occasionally remote

Résumé du poste

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

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Quality Assurance

Regulatory Affairs

English (C1)

Teamwork

Formation

Bachelor's Degree in Engineering (Industrial, Organizational)

Outils

AI tools

Data automation tools

Description du poste

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