Establishment Labs

QA Engineer

• Apply company policy and procedures
• Supports the design controls process during development of new medical devices or design changes including: Planning, Design requirements, Design Validation and Verifications, and Design transfer specifications.
• Support Design related root cause and corrective action investigations
• Lead the Usability Engineering activities including: Usability strategy plan, Usability strategy report, Formative and Summative Evaluations.
• Review and approve Engineering documentation, such as: Design controls deliverables, CAPAs, NCs, CCPs, etc.
• Coordinates the creation, review and updates of Risk Management Files and Reports for all applicable product families along with the Ops Quality and the Quality System departments.
• Other functions may be assigned by management based on his/her knowledge and experience.

Quality Assurance Engineer, Design