Surgery Quality & Compliance Analyst

Biopharma Asia; Bogotá; On-site; COP 60,000,000 - 95,000,000; Full time

Job summary

Johnson & Johnson in Bogotá seeks a Surgery Commercial Quality Analyst to join the Business Quality Team. The role ensures compliance with the Quality Management System, supports investigations of non-conformances, and manages training and document control.

Responsibilities include Change Control, Technovigilance, product discontinuation, and collaboration with manufacturing for local reconditioning. English proficiency and a science-related degree are required.

Qualifications

• Minimum 2 years of work experience in Quality Systems (GMP) preferably in medical devices.
• A bachelor’s degree is required. A degree in science, engineering, chemistry, pharmacist, administration or related field is preferred.
• English (min B1).
• Operation of Microsoft Office.
• Knowledge on SAP and Excel is desirable.
• Quality System courses are desirable.

Responsibilities

• Ensure compliance with company policies, procedures, and quality standards.
• Supports the implementation of applicable requirements to the Quality System, such as requirements from the MT Segment, global, regional or local requirements.
• Support investigations of non-conformances and definition of preventive and corrective actions through the analysis of root causes and participate in meetings with the other areas involved.
• Manage the training process, ensuring compliance with the metric defined for timelines and completion and complying with the minimum requirements established in the Curriculum Matrix.
• Support the document control and records management processes, ensuring compliance with the company procedures.
• Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation.
• Technovigilance Surveillance Responsible: Manage and report to health authorities serious and non-serious adverse events related to medical devices, as provided in resolution 4816 of 2008.
• Responsible for local product discontinuation and NPI (New product introduction) processes and evaluation of Local Opportunity Products (POLO)
• Interaction with manufacturing plants to manage local reconditioning in compliance with the company's Repack & Relabel requirements.
• Document Non-Conformities in the DES (Designated Electronic System); ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness.
• Deployment of recall, stop shipment and sanitary alerts processes as required by Quality Management.
• Perform handling material data transactions in SAP (Master Data).
• Responsible for the shipment to the operating company of product complaint samples.
• Support other responsibilities according to the backup system established, in case that is required, the Commercial Quality Supervisor or Specialist will support the activities described in this job description.
• Ensures compliance with the Good Practices and EHS Regulations among other policies and guidelines of the company.

Skills

Strong written and verbal comms

Teamwork & collaboration

Planning & organization

English proficiency

MS Office proficiency

SAP knowledge

Education

Bachelor's degree in science/engineering/chemistry/pharmacist/administration

Tools

SAP

Excel

Job description

Johnson & Johnson in Bogotá seeks a Surgery Commercial Quality Analyst to join the Business Quality Team. The role ensures compliance with the Quality Management System, supports investigations of non-conformances, and manages training and document control.

Responsibilities include Change Control, Technovigilance, product discontinuation, and collaboration with manufacturing for local reconditioning. English proficiency and a science-related degree are required.