Experteer Overview
Experiencia, cualificaciones y habilidades interpersonales, ¿tiene todo lo necesario para triunfar en esta oportunidad? Descúbralo a continuación.
In this role you will ensure quality across Grifols' instrument portfolio for in vitro diagnostics. You'll work within the Instruments Quality Engineering team to support design, manufacturing, and lifecycle activities in compliance with ISO 13485, IVDR, and FDA QMSR. Collaborating with manufacturing, QC, and tech services, you will drive robust processes, investigations, and change controls to ensure product conformity. You'll contribute to a mission of delivering reliable diagnostic solutions that impact patient care. This is a chance to shape quality culture in a global, multidisciplinary setting and work on cutting-edge instruments.
Compensaciones / Beneficios
- Participate in QA activities across the instrument lifecycle: design, development, industrialization, manufacturing, release, post-market, and end-of-life management
- Ensure quality and compliance of raw materials, intermediates, finished instruments, and spare parts through qualification and deviation management
- Support manufacturing troubleshooting and collaborate with Production and QC to ensure robust processes and product conformity
- Collaborate on investigations and CAPA activities to achieve timely resolutions
- Manage and approve change controls for instruments, accessories and parts per regulatory and quality requirements
- Oversee calibration, verification and lifecycle management of analytical equipment and tooling in Manufacturing and QC
- Review and approve documentation including specs, risk files, manufacturing instructions, validation and QC methods
- Participate in industrialization, transfer, and validation of new processes or product changes for readiness and compliance
- Engage in customer complaint investigations including those from Technical xqysrnh Service
- Contribute to data analysis to monitor process performance and product quality
Responsabilidades
- Bachelor's degree in industrial engineering
- English: Advanced
- Minimum 2 years of experience in a similar role, preferably in the IVD sector
- Excellent communication skills
- Ability to analyze in an agile and decisive way
- Ability to articulate issues clearly and keep focus on objectives
- Ability to work well in a team
Requisitos principales
- flexible schedule
- occasional remote work
- benefits package