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 define preventive and corrective 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, new product introduction, and evaluation of Local Opportunity Products (POLO).
• Support change control, document control and records management, and deploy recalls, stop shipments and sanitary alerts.
• Manage training, samples (human and non-human use) and onboarding, and perform material data transactions in SAP.
• Support regulatory inspections and internal audits, 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; experience in medical devices, pharmaceuticals, pharmacovigilance or diagnostics is preferred.
• 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: experience supporting regulatory inspections and internal audits, and with NPI, product discontinuation or post-market activities.
• Preferred: familiarity with CAPA, root cause analysis, and interest in digital tools, process improvement, automation or AI.