Establishment Labs

Software Engineer

• Lead or conduct initial supplier assessments to determine whether suppliers have the capabilities to consistently meet Establishment Labs requirements, applicable standards, and regulatory requirements over time.
• Analyze supplier performance monitoring results and periodic reevaluations, or perform such evaluations when assigned, and take appropriate actions based on the results.
• Review Supplier Corrective Action Requests (SCARs), including containment, investigation, action plans, and effectiveness verification, and complete assigned activities when requirements are met.
• Lead or conduct supplier audits, both domestic and international, using on-site, remote, desktop, or virtual approaches as applicable.
• Prepare and review documentation for internal and external audits, and support interactions with auditors when required.
• Assess supplier-reported changes and execute Supplier Quality activities, including coordination with other departments when actions are assigned across functions.
• Lead efforts to identify opportunities for improvement in associated procedures and records and perform such changes in the documentation system.
• Conduct nonconformance (NC) and CAPA activities related to Supplier Quality, including root cause investigation, action implementation, and follow-up of assigned tasks.
• Lead the qualification of new or modified materials to verify their suitability for intended use and compliance with applicable requirements.
• Document Supplier Quality information in an accurate and timely manner after confirming the validity of the information being recorded.
• Design, maintain, update, and present Supplier Quality metrics to support monitoring, decision-making, and communication with relevant stakeholders.

Senior Engineer, Supplier Quality

Research Analyst

• Coordinate and oversee clinical trial activities throughout the study lifecycle.
• Provide strategic guidance and oversight, mentoring junior staff and coordinating with management.
• Develop and maintain clinical trial documentation.
• Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials.
• Create, implement and administer methods and procedures to enhance operations, as appropriate.
• Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for product registration and technical file (Clinical Evaluation Report).
• Oversee clinical trial operations and site performance.
• Clinical trials reports creation.
• Submission package readiness for Ethics Committees approval; including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others.
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification, collecting completed CRF forms.
• Support and review of statistical plans for clinical trials
• Monitor any updates that may arise about ethical considerations, scientific principles, legislation and regulatory guidelines, and clinical evaluation process.
• Identify and communicate study-related risks and operational challenges
• Participate in continuous improvement initiatives related to clinical processes.

Senior Engineer, Supplier Quality

Clinical Research Associate