Quality Assurance Specialist

Grifols; Parets del Vallès; Hybrid; EUR 38,000 - 52,000; Full time

Benefits offered by this job

Permanent contract

Parets del Vallès location

Occasional remote work

Flexible schedule

Job summary

Grifols in Parets del Vallès is seeking a Quality Assurance Specialist to ensure product quality across the lifecycle of diagnostic products for blood typing, in compliance with ISO 13485, IVDR, and QMSR. You will participate in QA activities, monitor intercompany quality indicators, investigate NCs and complaints, and approve documentation and processes.

Requirements include a Health Sciences degree, Advanced English, at least 2 years in a similar role (IVD preferred), strong communication and

Qualifications

• Bachelor's degree in Health Sciences required.
• English: Advanced level required.
• Minimum 2 years of experience in a similar position (IVD sector preferred).
• Strong communication and analytical skills; team player.

Responsibilities

• Participate in QA activities across product lifecycle (ISO 13485, IVDR, QMSR).
• Manage intercompany quality indicators and QA meetings.
• Investigate NCs/Complaints; document traceability and follow-up.
• Assure quality of raw materials through qualification and deviation management.
• Support manufacturing troubleshooting with QA collaboration.
• Collaborate on CAPAs and investigations; ensure timely resolution.
• Review/approve docs, specs, risk files, and QC methods.
• Assist in industrialization, transfer and validation of changes.

Skills

Communication skills

Analytical thinking

Team collaboration

English proficiency

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

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

We are here to help.

Grifols is an equal opportunity employer.

Benefits Package

• Contract of Employment: Permanent position
• Location: Parets del Vallès
• Flexibility for U Program: Occasionally remote
• Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
• Location: SPAIN : España : Parets del Valles:[[cust_building]]
• www.grifols.com

Learn more about Grifols