Establishment Labs

Quality Assurance Engineer, Design

Establishment Labs

full-time

Posted on:

Origin:  • 🇨🇷 Costa Rica

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Job Level

JuniorMid-Level

About the role

  • 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.

Requirements

  • Bachelor´s degree in Industrial Engineer, Quality Engineer, Industrial Production Engineer, Biomedical Engineer, Mechanic Engineer, Chemical Engineer, Material Engineer
  • 2 years of Experience in Medical Industry within Quality Department
  • Intermediate English (written & spoken)
  • Team player
  • Strong communication skills
  • Analytical thinking
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