Surgery Commercial Quality Sr. Analyst

About the role

Johnson & Johnson is hiring a Surgery Commercial Quality Sr. Analyst based in Bogotá, Colombia. The role ensures compliance with the Quality Management System and local quality regulations, sets up quality assurance programs and procedures, and covers quality, technovigilance, product lifecycle, change control, training and samples management.

Key responsibilities

• Ensure compliance with company policies, quality standards and the MT LATAM Quality Manual, and support the implementation of Quality System requirements
• Investigate non-conformances using root cause analysis, document them in the designated electronic system and follow CAPA and corrective/preventive actions
• Act as Technovigilance Surveillance Responsible, reporting serious and non-serious adverse events to health authorities and supporting technology-controlled reports, quarterly reports, product complaints and implantable card processes
• Handle local product discontinuation, NPI and POLO product analysis, and interact with manufacturing plants on reconditioning and repack & relabel
• Support change control, document control and records management, and deploy recalls, stop shipments and sanitary alerts
• Manage training and samples (human and non-human use), support onboarding and the onboarding process
• Enter material data in SAP, support product master data, RIM, computer system validation and purchase orders for the Commercial Quality area
• Support regulatory body and internal audit inspections, and act as backup for the Commercial Quality Supervisor or Specialist

Required profile

• Bachelor's degree in Pharmaceutical Chemistry, Biomedical Engineering, Chemical Engineering or a related scientific, engineering or healthcare field
• Experience or knowledge of Quality Management Systems in a regulated environment
• Preferred: experience in medical devices, pharmaceuticals, pharmacovigilance, diagnostics or other highly regulated healthcare fields
• Preferred: experience supporting regulatory inspections and internal audits, and with NPI, product discontinuation or post-market activities
• English proficiency is mandatory, with the ability to join regional or global meetings and projects

Required skills

• Preferred: knowledge of SAP / master data, document control, records management and regulatory requirements
• Preferred: knowledge of CAPA, root cause analysis and non-conformance management
• Preferred: familiarity with digital tools, process improvement, automation, AI or digital solutions