Work Flexibility: HybridWhat you will do:Executes Quality Assurance / PMS (Post-Market Surveillance) activities in line with procedures and country-specific responsibilities.Collects, organizes, and maintains RAQA (Regulatory Affairs & Quality Assurance) intelligence at local, regional, and global levels.Identifies and implements new regulatory procedures, SOPs (Standard Operating Procedures), and continuous improvement opportunities.Acts as Quality Assurance Leader, defining KPIs (Key Performance Indicators), reporting performance, risks, and issues to local leadership.Leads audits (Third Party, Competent Authority, Notified Body) within the local organization.Supports Latin America/Country Quality Assurance teams, talent development, and integration of new acquisitions.Represents Stryker as Quality Assurance subject matter expert in local industry associations and advocacy activities.Ensures collaboration with manufacturing and design divisions to support local Quality Assurance and commercial needs.What you will need:Required:Bachelor’s degree in a relevant field (Pharmaceutical Chemistry, Engineering, Pharmacy, or related).Minimum of 3 years of experience in Quality Assurance.Strong expertise in Quality Management Systems.Bilingual: Spanish and English.Preferred:Advanced Degree.RAC (Regulatory Affairs Certification).Expertise in ISO 13485 standards.Experience in Medical Devices.Travel Percentage: 10%
