Quality Management Systems Sr Specialist, Capa-medical Devices (Bogotá)

Location : Bogota, Capital District, Colombia

Job Category : Quality & Regulatory

Job # : 4678

Employment Type : Full-Time

How You'll Create Impact

• Provides coaching for CAPA investigation from initiation through containment, root cause analysis, implementation, and verification of effectiveness.
• Provides facilitation and coaching on the problem solving process and challenges technical content.
• Interfaces with CAPA owners/teams to coach and facilitate progression through the CAPA process.
• Assists with risk analysis of issue and ensures proper containment actions are applied.
• Verifies all procedural CAPA requirements are met.
• Assists to identify and elevate resource constraints/requirements, as applicable.
• Reviews CAPA files to ensure the files are audit ready, clearly tell the story, contain all required objective evidence, etc.
• Other quality tasks,...