Engineer ll Quality
Alajuela, Costa Rica
hace 3 días

Job Description

Support the development and manufacture of medical devices. Work with Manufacturing and R&D to resolve product quality issues.

Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties :

  • Work with Manufacturing Engineers to review process changes and resolve product quality issues.
  • Work with suppliers to maintain high quality levels of incoming production materials.
  • Conduct quality audits of suppliers.
  • Work with R&D Engineers to support implementation of new products by reviewing quality and testing plans.
  • Work with R&D and Manufacturing Engineers to develop the DFMEA and PFMEA.
  • Work with R&D and Manufacturing Engineers to develop test protocols and reports (design verification, design validation, process qualification, and process validation).
  • As assigned, maintain various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
  • Perform additional duties and responsibilities as assigned.
  • Qualifications

  • Bachelor’s degree in Engineering or related field.
  • Minimum of two (2) years of related experience.
  • Strong written and verbal communication skills.
  • Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc.).
  • Desired Qualifications

  • Knowledge of medical product manufacturing.
  • Strong mathematics skills.
  • Ability to understand the technology related to MicroVention’s products.
  • Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
  • Outside US

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