September 16, 2024

Establishment Labs

OTHER

Tecnico de Calidad Turno C (Domingo a Sabado 10:00pm a 6:00am)

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.

Work Schedule available: Sunday to Saturday from 10:00pm to 6:00am

About the Role:

Manages the Quality activities that support good manufacturing practices and processes to assure
they comply with local procedures, and applicable regulations and standards.

Main Responsabilities:

Perform and report the results of process monitoring.
Perform tests to determine the sealing strength of the gasket
Perform sterilization certificates.
Approve or execute the analysis of routine sterilization runs.
Support the different departments through the “QM Support” ticketing platform.
Support the development of policies and procedures related to quality checks and releases during
the process.
Ensure that the work areas are clean and orderly according to the official version of the process
procedures.
Approve, execute, and secure required changes using SAP S-4 HANA application.
To enforce compliance with Good Manufacturing Practices (GMP).
Prepare and update quality reports.
Perform training of new Technicians in the area as requested by the Quality Engineer.
Work with engineers in the developing, writing, execution, and reporting of validation efforts such
as equipment qualification, process validation, and Quality Plans, among others.
Execute activities related to Quality Inspector as needed

Job Requirements:

Advanced student in Engineering or related fields in process (50%) or certified quality
technician completed.
Two years previous experience in Good Manufacturing Practices (GMP) and good practices
documentation.
Ability to read and understand technical documents in English, such as standards,
guidelines, and regulations. Ability to write reports in English. Medium (B1) level English.
Written/verbal communication skills.
Understanding of Quality Management System (QMS).
Ability to use commercial software packages (i.e. Windows, or similar).
Ability to use word-processing programs (i.e. Microsoft Word), and spreadsheet programs (i.e. Intermediate Microsoft Excel).
Desirable experience in the use of laboratory measurement equipment (ruler, intron,
Gauges, Go/No go, caliper, etc).
Desirable knowledge in the interpretation of drawings and reading of specifications.
Desirable knowledge in using SAP system

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.