Quality Assurance Specialist

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

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 opportunities that foster an inclusive environment.

We are looking for a Quality Assurance Specialist for ensuring the quality of the products of the Diagnostic Grifols division, dedicated to the design and manufacture of in vitro diagnostic systems for blood typing.

What your main responsibilities will be

• Participate in Quality Assurance activities across the entire lifecycle of diagnostic products, including design and development, industrialization, manufacturing, release, post‑market activities, and end‑of‑life management in accordance with ISO 13485, Regulation (EU) 2017/746 for IVDR, and FDA Quality Management System Regulation (QMSR).
• Participate in the quality management of intercompany processes ensuring alignment with applicable Quality System requirements.
• Monitor intercompany quality indicators and agreed KPIs, ensuring their follow-up and integration into Quality Committees and PMSR-related activities, where applicable.
• Collaborate in investigations, NCs, Complaints, CCs APAs related to intercompany activities, ensuring appropriate documentation, traceability and follow-up according to applicable procedures.
• Ensure the quality and compliance of raw materials, intermediate products and finished instruments, including spare parts, through active involvement in qualification, requalification and deviation management activities.
• Support and evaluate manufacturing area troubleshooting, collaborating closely with Production and Quality Control Department to ensure robust processes and product conformity.
• Collaborate with Manufacturing and Quality Control in activities related to investigations and CAPAs, ensuring timely and effective resolution.
• Review and approve product and process documentation, including specifications, risk management files, manufacturing instructions, validation documentation and quality control methods.
• Participate in industrialization, transfer and validation of new processes, products or product changes, ensuring readiness for routine manufacturing and compliance with regulatory requirements.

Who you are

• Bachelor’s degree in a Health Sciences.
• English: Advanced level.
• Minimum 2 years of experience in a similar position, preferably within the IVD sector.
• You have excellent communication skills.
• You have the ability to analyze in an agile and decisive way.
• You are able to expose the issues in a clear and organized way focused on the objective.
• You have the ability to work as part of 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 at www.grifols.com.

We are here to help.Grifols is an equal opportunity employer.

Flexibility for U Program:

Occasionally remote

Flexible schedule:

Monday-Thursday 7-10 to 16-19h and Friday 8-15h.

Benefits package

Contract of Employment:

Permanent position