Design Quality Assurance Engineer (DQA)

About the role

Establishment Labs designs, develops and manufactures medical aesthetic devices and wellness solutions, with production in Costa Rica. As a Design Quality Assurance (DQA) Engineer you represent the quality perspective across the medical device product lifecycle, from new product development to design changes and sustaining activities. You partner with R&D, Regulatory Affairs, Clinical Affairs, Manufacturing and other teams to support design controls, risk management, usability engineering and regulatory compliance.

Key responsibilities

• Provide quality and compliance input to new product introduction projects, design changes, supplier and process changes.
• Support design controls: planning, user needs, inputs and outputs, design reviews, design V&V and design transfer in an FDA/EU MDR environment.
• Lead design validation and usability engineering activities, including strategy, formative and summative evaluations, and their records and reports.
• Maintain product risk management documentation such as hazard analyses, FMEAs, risk management files and reports.
• Review and approve engineering documents and design control deliverables such as specifications, test methods, protocols and drawings.
• Support investigations of nonconformances, CAPAs and risk-based impact assessments.
• Partner with Regulatory Affairs on annual reviews, recertifications and registration responses.
• Support internal and external audits and champion compliance with policies, work instructions and SOPs.

Required profile

• Bachelor's degree in Industrial, Industrial Production, Biomedical, Mechanical, Chemical, Materials, Electrical or Electronic Engineering.
• At least 2 years of experience in a medical industry quality department as an engineer.
• Advanced English (B2+).
• Self-motivated, able to manage multiple priorities, detail-oriented, flexible and strong communicator.

Required skills

• Knowledge of FDA QMSR, EU MDR, ISO 13485, ISO 14971, ISO 62366 and IEC 60601.
• Validation and statistical techniques.

The schedule is Monday to Friday, 8:00 a.m. to 5:00 p.m., in a hybrid role. Selection involves a test to the process, an English assessment, an assessment center evaluation and a competency-based interview with the hiring manager and team.