Surgery Commercial Quality Analyst

About the role

Johnson & Johnson is looking for a Surgery Commercial Quality Analyst to join its Business Quality Team in Bogotá. The role ensures compliance with the Quality Management System and local quality regulations, and establishes and maintains quality assurance programs, procedures and controls so that product and quality-system performance is continuously measured to drive improvement.

Key responsibilities

• Support investigations of non-conformances, define preventive and corrective actions and take part in cross-area meetings.
• Manage the training process against defined timelines and the Curriculum Matrix, and support document control and records management.
• Support the change control process so that changes are evaluated, registered, reviewed and approved before implementation.
• Act as Technovigilance Surveillance Responsible: report serious and non-serious adverse events to health authorities under resolution 4816 of 2008.
• Handle local product discontinuation and NPI processes, evaluate Local Opportunity Products (POLO), and coordinate with manufacturing plants on local reconditioning under Repack & Relabel requirements.
• Document non-conformities in the designated electronic system (DES) and support deployment of recalls, stop shipments and sanitary alerts.
• Handle material data transactions in SAP (master data) and send product complaint samples to the operating company.
• Ensure compliance with Good Practices and EHS regulations and other company policies.

Required profile

• Minimum 2 years of experience in quality systems (Good Manufacturing Practices), preferably in medical device companies.
• Bachelor's degree; science, engineering, chemistry, pharmacy, administration or a related field preferred.
• English at least B1 level, and good communication in English and Spanish.
• Strong written and verbal communication, planning and organization, prioritization, teamwork and results orientation.

Required skills

• Microsoft Office.
• SAP and Excel are desirable.
• Quality system courses are desirable.