Mexico City, Mexico · Hybrid
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 …
Skills: Supplier Quality Management, Auditing, Root Cause Analysis, Technical Documentation Review, ISO 13485
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The Senior Engineer leads supplier quality activities, including qualification, performance monitoring, and the management of audits and nonconformances. The role ensures that materials and services meet regulatory requirements and quality standards through risk-based decision-making and continuous improvement.
Requires a Bachelor's degree in Engineering or Science and over 5 years of experience in supplier quality within the medical device or pharmaceutical industry. Candidates must have advanced English proficiency and strong knowledge of ISO 13485 and auditing techniques.
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:
Requirements:
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.
Establishment Labs® (NASDAQ:ESTA) is a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market by designing, developing, manufacturing, and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at two FDA-compliant state-of-the-art facilities in Costa Rica and are currently approved for commercial distribution in over 70 countries through exclusive distributors or a direct salesforce. In March 2018, Establishment Labs® received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implants® clinical trial in the United States.
Offices: Coyol Free Zone, B25, Coyol , Alajuela 20102, CR
Establishment Labs® (NASDAQ:ESTA) is a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market by designing, developing, manufacturing, and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at two FDA-compliant state-of-the-art facilities in Costa Rica and are currently approved for commercial distribution in over 70 countries through exclusive distributors or a direct salesforce. In March 2018, Establishment Labs® received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implants® clinical trial in the United States.
Offices: Coyol Free Zone, B25, Coyol , Alajuela 20102, CR
