Quality Engineer - Fixed Term

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

Responsible for managing the areas related to the quality engineering aspects of the operation. Promotes and leads the achievement of the higher quality performance, both at the operations, product development and product performance levels, as well as an environment of continuous quality improvement to support the Corporate’s Business and Operational Excellence goals. 

Main Responsibilities

• Organize continuous improvements and opportunities for change in QE processes.
• Manages strategic QE projects
• Ensure compliance with appropriate regulatory, quality requirements and company policies
• Manages and resolves complex quality relation issues
• Supports Operations ensuring appropriate process controls are in place to prevent product performance quality issues
• Supports SAP implementation and sustaining activities
• Support the Quality Engineering area
• Developing, writing, execution and reporting of validation efforts such as Computer System Validation
• Executes protocols for validation, qualifications, and computer software.
• Investigates and researches equipment, process, computer software to develop protocols to confirm by examination and provision of objective evidence that they consistently produce a result or product meeting its predetermined specifications
• Supports management in developing the validation strategy, implements and monitors it, and reports status to management
  

Technical Requirements:

• Bachelor Degree in industrial engineering, chemical engineering, industrial chemical engineering, biomedical engineering, electromedicine or related filed. 
• Advanced English (speaking and reading)
• 2 years of experience in medical industry.

Evaluation:

• English Test. Need to get B2 scored.
• Assessment Center
• Competency-based interview with hiring manager.

Important:

This role is offered on a fixed-term basis for 11 months.

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.