In this role you ensure quality in both processes and finished products, while ensuring compliance with the organization’s standards. You will collaborate across QA activities, audits, and CAPA processes to support a scalable quality system. You’ll contribute to validations, change control, and product integrity through cross-functional engagement. The position offers exposure to global standards and complex regulatory environments, with a focus on impactful quality improvements.
Compensaciones / Ventajas
- Participate in internal and external quality system audits
- Manage preventive and corrective actions (CAPAs)
- Support validation of facilities, equipment, processes, and IT systems
- Develop and execute Test Method Validations (TMVs) and Software Validations
- Manage and review product/process/System change controls from QA perspective and implement actions
- Support Health Hazard Evaluations (HHE/HHED), product holds and quarantines
- Participate in production transfer projects (Transfer-in/Transfer-out)
- Assist in investigating product complaints for devices manufactured in ZimVie Spain
Responsabilidades
- University degree in Engineering or Advanced Vocational Degree with relevant experience
- Proficiency in English for collaboration with US plant and external auditors
- Knowledge of Excel and data analytics (Power BI); ERP systems knowledge with Oracle a plus
- Basic statistics related to process control and sampling
- Knowledge of Quality Management System and applicable standards (ISO 9001/13485 or 21 CFR 820)