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:


Support for conducting testing procedures to ensure that products and processes comply with quality
standards.


Necessary Duties and Responsibilities include the following:

• Supports the companies’ customer complaints system per the procedures and policies established
  by the Quality System and ensures it is appropriately implemented and compliant with applicable
  regulations.
• Recommends test, techniques and methods for the inspection of the materials, the calibrations of
  the equipment and the validations of equipment, product or processes.
• Support research, development and manufacturing engineering during new product start-ups and
  establishes tools and method for testing new products and processes.
• Responsible for continual improvement activities to enhance the quality system.
• Investigates customers complaints on existing products.
• Root cause analysis and implementation of corrective action for process related concerns.
• Follow Quality performance indicators.
• Follow controls of the documentation related to the quality system.
• Ensures a system is in place to provide customers a timely respond related to product claims.
• Participate and collaborate with team members to achieve consistent processes while identifying
  process improvements to drive efficiency and compliance.
• Coordinate and manage all activities to maintain the records of all laboratory testing.
• Conducts CAPA activities directed to address adverse trends identified as part of the PMS activities.
• Assures all actions required to optimize the quality, manage the risk, and maintain the
  compliance of our products are planned and completed, and that the results drive quality and
  quality system actions.
• Other functions may be assigned as per business needs and management determination.

Requirements

• Engineering student, health sciences or related career.
• High School Diploma.
• Previous Quality or engineering experience (preferred).
• If not a career degree, at least Minimum 3+ years of experience in medical devices.
• Quality, Industrial, electronic or mechanical engineering student (preferred).
• Knowledge of ISO 9001, ISO 13485, FDA, CE Mark standards and GMP´s desired.
• Experience in the Quality Assurance of medical devices.
• Intermediate English and writing skills.
• Computer knowledge is required: spread sheets, word processor, other utilities, basic
• knowledge of commercial software package (i.e. Windows or similar) and basic computer
  configuration. Including statistical/data analysis and report writing skills.
• Ability to handle multiple tasks in a high volume environment where meeting customer delivery
  dates demands urgency.
• Demonstrate strong organizational skills and strong interpersonal skills in order to interact with
  the customer, co-workers and manufacturing departments.
• Proven leadership and ability to drive teams.
• Solid communication and interpersonal skills.
• Highly developed soft skills.
• Ability to handle confidential information.
• Multitasking abilities.

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.