Quality Assurance Specialist: IV Diagnostics (Remote)

Grifols, S.A; Parets del Vallès; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Benefits package

Flexible schedule

Occasionally remote

Job summary

Grifols, S.A. seeks a Quality Assurance Specialist for the Diagnostic Grifols division in Catalonia.

You will oversee QA activities across the product lifecycle for in vitro diagnostics, ensuring compliance with ISO 13485, IVDR, and QMSR, and collaborating with cross‑functional teams to uphold quality standards. The role requires a Health Sciences degree, 2+ years in a similar QA role (IVD preferred), excellent communication, and the ability to analyze issues decisively within a team.

Qualifications

• Bachelor’s degree in Health Sciences required.
• English at an Advanced level.
• Minimum 2 years in a similar position, preferably in the IVD sector.
• Excellent communication skills.
• Ability to analyze in an agile and decisive way.
• Ability to work as part of a team.

Responsibilities

• Participate in Quality Assurance across the product lifecycle (design, development, industrialization, manufacturing, release, post‑market, EOL) per ISO 13485, EU IVDR, and QMSR.
• Manage intercompany quality processes aligning with Quality System requirements.
• Monitor KPIs and reports; escalate in Quality Committees and PMSR activities.
• Support investigations, NCs, Complaints, CCs, APAs with proper documentation and traceability.
• Ensure quality of raw materials, intermediates, and finished instruments; manage qualifications and deviations.
• Assist in troubleshooting with Production and Quality Control to ensure robust processes.
• Collaborate on CAPAs and investigations; ensure timely resolutions.
• Review and approve product/process documentation and validation files.
• Support industrialization, transfer and validation of new processes/products.

Skills

English (Advanced)

Communication skills

Analytical thinking

Teamwork

Agile mindset

Education

Bachelor’s degree in Health Sciences

Job description

Grifols, S.A. seeks a Quality Assurance Specialist for the Diagnostic Grifols division in Catalonia.

You will oversee QA activities across the product lifecycle for in vitro diagnostics, ensuring compliance with ISO 13485, IVDR, and QMSR, and collaborating with cross‑functional teams to uphold quality standards. The role requires a Health Sciences degree, 2+ years in a similar QA role (IVD preferred), excellent communication, and the ability to analyze issues decisively within a team.