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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 / Incentivos
• 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 xqbhyrx 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)