Associate I, Quality Assurance - LatAm
Core
Process and investigate product defect complaints, monitor trending, and ensure compliance with regulatory requirements for medical devices.
Role type
Associate Quality Assurance (Complaints Handling)
Builds
Product defect investigations and regulatory compliance documentation
Domain
Medical Devices / Pharmaceuticals
Required skills
Complaint handling, regulatory compliance (GxP), documentation, cross-functional collaboration, process improvement
Preferred skills
Pharmacovigilance, Technovigilance, ISO 13485, Quality Management Systems
Technologies
Standard software platforms
Responsibilities
Process, investigate, and monitor trending of product defect complaints; Collaborate with Medical Safety and R&D on adverse events; Ensure compliance with regulatory agencies' reporting requirements; Support complaint activity monitoring and suggest process modifications; Maintain accurate documentation and complete required training
Seniority
Associate, entry-level IC