Would you like to join an international team working to improve the future of healthcare? 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, developing, producing and marketing 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 an Instruments Quality Engineer responsible for ensuring the quality of instruments in the Diagnostic Grifols division, dedicated to the design and manufacture of in‐vitro diagnostic systems for blood typing.
Responsibilities
Participate in Quality Assurance activities across the entire lifecycle of diagnostic instruments, 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).
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.
Manage, assess and approve change control activities related to instruments, accessories and spare parts, ensuring compliance with applicable regulatory and quality requirements.
Participate in the calibration, verification and lifecycle management of analytical equipment and tooling used in Manufacturing and Quality Control.
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.
Participate in customer complaint investigations, including those reported by Technical Service.
Collaborate in data analysis to monitor process performance and product quality.
Qualifications
Bachelor's degree in industrial engineering.
Advanced level of English.
Minimum 2 years of experience in a similar position, preferably within the IVD sector.
Excellent communication skills.
Ability to analyze in an agile and decisive way.
Ability to expose issues in a clear and organized way focused on the objective.
Ability to work as part of a team.
What We Offer
Flexibility for U Program: Occasionally remote.
Flexible schedule: Monday‐Thursday 7‐10 to 16‐19h and Friday 8‐15h.
Benefits Package: Permanent position.
Location: Parets del Vallès, Spain.
Grifols is an equal opportunity employer.
#J-18808-Ljbffr