Surgery Commercial Quality Analyst

About the role

Johnson & Johnson MedTech is looking for a Surgery Commercial Quality Analyst in Buenos Aires, Argentina. The role supports the execution and governance of Commercial Quality processes across the Local Operating Company, focusing on quality oversight, compliance and continuous improvement in warehouse and distribution operations. You will partner with cross-functional teams and external partners to maintain audit readiness and support business continuity in a highly regulated environment.

Key responsibilities

• Maintain and support the Quality Management System (QMS) in line with company standards, procedures and local regulatory requirements, ensuring quality controls and product traceability across the supply chain.
• Lead investigations of deviations, nonconformances and compliance gaps, including root cause analysis and corrective and preventive actions.
• Perform product release for commercialization in Argentina and support the release process for Uruguay.
• Ensure quality compliance for marketing companies, external manufacturers, packaging and labeling, including Repack & Relabel standards.
• Manage document control and QMS documentation, and train warehouse operations personnel on quality procedures.
• Monitor QMS performance, including monthly quality metrics and Third-Party Logistics (3PL) indicators, and support Product Complaint Management.
• Coordinate Stop Shipment notifications and take part in internal audits, external regulatory inspections and corporate audits.
• Drive continuous improvement with Deliver Operations and 3PL partners, conduct GEMBA walks at the 3PL warehouse, and oversee Master Data quality activities.

Required profile

• Bachelor's degree in Pharmacy, Biochemistry, Engineering, Life Sciences or a related field.
• Previous experience in Quality, Quality Assurance, Quality Systems, Operations Quality or a related function in a regulated industry.
• Intermediate English proficiency; intermediate to advanced Microsoft Office.
• Preferred: experience in medical devices, pharmaceuticals or healthcare; warehouse, distribution or 3PL experience; knowledge of GxP, product release, complaint management and audits; familiarity with Argentinian medical device regulations; SAP or similar ERP experience.