Quality Assurance Technician (ta)

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. 

Objective:

The objective of the role is to manage the Quality activities that support good manufacturing practices and processes to assure they comply with local procedures, and applicable regulations and standards.

Necessary Duties and Responsibilities include the following:

• Perform and report the results of process monitoring.

• Perform tests to determine the sealing strength of the gasket.

• Perform sterilization certificates.

• Support the development of policies and procedures related to quality checks and releases during

• 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.

• 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.

Requirements:

• Advanced student in Engineering or related fields in process (50%) or certified quality technician completed.

• 2 years previous experience in Good Manufacturing Practices (GMP) and good practices documentation.

• Desirable minimum 2 year of experience in the medical devices industry.

• 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. (Desirable)

• 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, instron, Gauges, caliper, etc).

• Desirable knowledge in the interpretation of drawings and reading of specifications.

• Desirable knowledge in using SAP system.

Evaluation:

• Assessment, minimum score of 80 to continue with the process.

• Competency-based interview.

• English Test.

Important: On Site position.

• TA: Monday to Saturday from 6:00 am to 2:00 pm

Some Benefits:

• Health insurance and Life insurance

• Employee assistance program (EAP) this service offers you and your family support with any work or personal issue, including short-term professional counselling and connecting you to local resources to help you manage emotional, practical or physical needs.

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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.

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