01 oct
Stryker
Bogotá
Work Flexibility: Hybrid
What 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 integral 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%
Required Skill Profession
Operations Specialties Managers
📌 Associate Manager, Quality Assurance NOLA
🏢 Stryker
📍 Bogotá
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.