Senior Supplier Quality Engineer

About the role

The Senior Engineer, Supplier Quality leads and executes supplier quality activities, including qualification, performance monitoring, audits, and management of nonconformances and CAPA/SCARs. The role works closely with internal teams and suppliers to ensure materials and services meet stringent quality standards and regulatory requirements. Strong attention to detail, timely follow‑up, and effective communication are essential.

Key responsibilities

• Lead or conduct initial supplier assessments to verify capability to meet Establishment Labs requirements, applicable standards, and regulatory expectations.
• Analyze supplier performance monitoring results and periodic reevaluations, taking appropriate actions based on findings.
• Review Supplier Corrective Action Requests (SCARs), including containment, investigation, action plans, and effectiveness verification.
• Lead or conduct supplier audits (domestic and international) using on‑site, remote, desktop, or virtual approaches.
• Prepare and review documentation for internal and external audits and support interactions with auditors.
• Assess supplier‑reported changes and coordinate Supplier Quality activities with other departments.

Required profile

• Senior‑level individual contributor with a high degree of independence.
• Strong technical judgment and ability to lead resolution of complex quality issues.
• Effective cross‑functional collaboration and risk‑based decision‑making.
• Ability to manage multiple priorities while ensuring regulatory compliance.

Required skills

• Supplier Quality Management
• CAPA (Corrective and Preventive Action) processes
• SCAR (Supplier Corrective Action Request) handling
• Supplier Audits (on‑site, remote, virtual)
• Regulatory compliance knowledge (medical device standards)