Surgery Commercial Quality Sr. Analyst

Johnson & Johnson seeks a Senior Analyst in Commercial Quality for Surgery products based in Bogotá, Colombia. The role ensures compliance with quality management systems, regulatory requirements, and post-market surveillance obligations for medical devices in the Latin American market.

Responsibilities

• Ensure compliance with Quality Management System policies, procedures, and local regulatory requirements applicable to Surgery products
• Manage Technovigilance reporting and post-market surveillance activities, including adverse event documentation and health authority submissions
• Support non-conformance investigations, root cause analysis, and implementation of corrective and preventive actions
• Oversee product complaint processes, sample collection, and traceability in accordance with Colombian health authority standards
• Execute change control processes, document control, and records management to maintain quality system integrity

Requirements

• Bachelor's degree in Pharmaceutical Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific/engineering/healthcare field
• Experience or knowledge in Quality Management Systems within regulated environments
• Knowledge of Technovigilance, Post-Market Surveillance, Product Complaints, CAPA, Non-Conformance Management, or Change Control
• Experience with SAP systems and master data management
• Proficiency in Spanish and English for regulatory and operational communications
• Familiarity with Colombian health authority regulations and medical device requirements