Quality Assurance Engineer

at  Establishment Labs

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.

JOB REQUIREMENTS:

• Industrial Engineer, Business Administrator, or other careers related to business-related sciences completed or at least 90%.
• Minimum 2 years of experience in similar roles
• Intermediate English (reading and writing)
• Ability to use word-processing programs (i.e. Microsoft Word), and spreadsheet programs (i.e. Microsoft Excel).
• SAP knowledge
  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

ABOUT THE ROLE

Manages the quality activities supporting manufacturing and distribution processes to ensure compliance with local procedures, applicable regulations, and standards.
Available schedules: Monday to Friday from 3:30pm - 10:00pm and Saturday from 6:00am to 3:00pm
Monday to Saturday from 2:00pm to 10:00pm

MAIN RESPONSIBILITIES

• Provide guidance and support teams from operational areas (Manufacturing, Facilities, Maintenances and others)
• Lead and promote continuous improvement efforts in terms of quality and efficiency
• Own and/or review Non- Conformity Events.
• Own, execute and/or review for approval different Quality Management System documents, such as CAPAs (as required by the manager), Quality Plans and others.
• Assesses changes in manufacturing processes
• Coordinate, evaluate and support the different projects assigned to them
• Prepare reports to management
• This position may supervise QA technicians and/or QA inspectors (as required by the manager).
• Support Establishment Labs sites worldwide (e.g., Brazil, the EDC, and direct markets).
• Participates in the validation strategy
• Ensure compliance with quality standards and procedures in the operating areas of the company.