Sr Engineering, Supplier Quality

About Us:

Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.

Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.

Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.

This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.

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 collaborates with internal teams and suppliers to ensure materials and services meet quality standards and regulatory requirements.

It involves accurate and confidential management of quality documentation, with a strong focus on attention to detail, timely follow-up, and effective communication.

The position directly impacts supplier compliance, product quality, and supply continuity, while handling challenges such as multiple priorities and regulatory compliance.

As a senior-level individual contributor, this position is expected to operate with a high degree of independence, apply sound technical judgment in supplier quality matters, and provide leadership in the resolution of complex issues through effective cross-functional collaboration and risk-based decision-making.

The role requires strong autonomy, sound technical judgment, and leadership in solving complex issues, while driving continuous improvement in supplier quality processes.

Main responsibilities:

• 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:

• Bachelor’s degree in Engineering, Science, or related field.
• Advanced English (speaking and reading).
• Strong knowlegde 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).

Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.

At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.