Senior Engineer, Supplier Quality

Establishment Labs

Senior Engineer leading supplier quality activities at Establishment Labs, which innovates in women's health and aesthetics. Overseeing supplier compliance and quality assurance of medical device materials.

Posted 6/14/2026full-timeCoyol • 🇨🇷 Costa RicaSeniorWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Science, or related field
Advanced English (speaking and reading)
Strong knowledge in auditing, root cause analysis, technical documentation review and supplier quality management
Training or coursework in ISO 13485, auditing techniques, root cause investigation or risk management, or demonstrated experience and knowledge in these areas
5+ years of experience in Supplier Quality and/or Supplier Development in the medical devices or pharmaceutical industry.
Availability for occasional domestic or international travel, if required, for supplier audits, training, or any other related activities (valid passport).

Benefits

Comp & perks

Health insurance
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

supplier assessmentssupplier performance monitoringSupplier Corrective Action Requests (SCARs)supplier auditsnonconformance (NC) activitiesCAPA activitiesroot cause analysistechnical documentation reviewSupplier Quality metricsqualification of materials

Soft Skills

leadershipcommunicationorganizational skillsanalytical skillsproblem-solving