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Design Quality Assurance Engineer

Costa Rica, Coyol, Alajuela · Job Posted May 25, 2026
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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

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