Design Quality Assurance Engineer (DQA)

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:

• As a
• Design Quality Assurance (DQA) Engineer you will represent the quality perspective throughout the medical device product lifecycle—from new product development to design changes and sustaining activities. You will partner with Research & Development (R&D), Regulatory Affairs, Clinical Affairs, Manufacturing, and other cross-functional teams to support robust design controls, risk management, usability engineering, and regulatory compliance, with patient safety and product performance at the center of every decision.

Main responsibilities:

Provide quality and compliance input to strategic innovation and new product introduction projects, as well as design changes , supplier changes, process changes, etc supporting commercially available products and business continuity.

• •Support the design controls process, including design planning, user needs, design inputs and outputs, design reviews, design V&V , and design transfer
• activities in an FDA/ EU MDR regulated environment .

Lead assigned design validation activities to demonstrate that predefined user needs and intended uses have been met, including planning, execution, and documentation.

Lead usability engineering activities, including usability strategy, formative and summative evaluations with intended users, and the associated records and reports.

Lead the creation , review, and maintenance of product risk management documentation, such as hazard analyses, FMEAs, risk management files, and risk management reports, with cross-functional stakeholders.

Review and approve, within the scope of DQA, engineering documents and design control deliverables, including specifications, test methods, testing protocols / reports, drawings, a mong other s .

Support design-related investigations for nonconformances, corrective and preventive actions (CAPAs), and risk-based impact assessments to resolve quality issues and sustain product compliance.

Partner with Regulatory Affairs on activities such as annual reviews, recertifications, and responses to technical questions related to product registrations; ensure compliance with applicable requirements and company procedures.

Champion compliance to company policies, work instructions and SOP s.

Support DQA activities during internal and external audits, as needed.

Expertise in the validation and statistical techniques to comply with associated regulatory and internal requirements.

Carry out other related responsibilities as assigned, based on the needs of the team and the role.

Requirements:

Bachelor´s degree in Industrial Engineer, Industrial Production Engineer, Biomedical Engineer, Mechanic Engineer, Chemical Engineer, Material Engineer, Electrical Engineer and Electronic Engineer.

At least 2 years of experience in Medical Industry within Quality Department (working as an engineer)

Advance English B2+ (written & spoken)

Soft skills:

Self - Motivated with a passion for solving problems and a bias for action.

Ability to manage multiple priorities while maintaining a commitment to quality and continuous improvement .

Teamwork.

Details - oriented.

Change Agility ; flexibility to adapt to changing priorities, processes, and regulatory requirements

Strong Communications skills (verbal and written) .

Experience with FDA QMSR, EU MDR, ISO 13485 , ISO 14971, ISO 62366 , and `IEC 60601 .

Test to the process:

Interview with Talent Acquisition

English Assessment

Assessment center Evaluation

Competency-based i nterview with the Hiring Manager and Team

The shift for this position is Monday through Friday, from 8:00 a.m. to 5:00 p.m. (Hybrid Role)

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.