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Design Quality Assurance Engineer

Establishment Labs

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Location:
Costa Rica , Coyol, Alajuela

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Design Quality Assurance Engineer will be expected to apply knowledge of design controls, human factors, risk management and quality engineering techniques to the development process of medical devices, as a member of one or more cross-functional teams. This role is responsible to ensure that products are developed in accordance with applicable regulatory requirements, customer expectations, industry standards and successfully transferred to manufacturing.

Job Responsibility:

  • 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, 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

Additional Information:

Job Posted:
May 25, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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