Instruments Quality Engineer
Parets del Valles, ES
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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. |
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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 Instruments Quality Engineer for ensuring the quality of the Instruments 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 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.
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 industrial engineering.
- 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. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!We look forward to receiving your application!
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying.
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
Location: Parets del Vallès
Location: SPAIN : España : Parets del Valles:[[cust_building]]