Quality Assurance Specialist II

hace 1 semana


San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

Job Summary

We are seeking a skilled Quality Assurance Specialist II to join our team at Viant Medical. As a key member of our quality assurance department, you will play a critical role in ensuring the highest level of quality in our Class II medical devices.

Main Responsibilities

  • Support the development and production of Class II medical devices by providing quality engineering expertise.
  • Represent quality in production process efforts, quality planning, process validations, FMEA, and risk analysis.
  • Maintain and manage quality compliance and supplier quality management.
  • Investigate finished goods variance and complaints, and support process improvement and quality assurance testing methodology.
  • Participate in or lead Corrective/Preventive Action initiatives.
  • Support internal/external and suppliers audits, vendor qualification, and training programs.
  • Contribute to quality/business initiatives, including business process improvement activities, documented Quality System re-architecture, and other cross-functional projects.

Key Qualifications

  • Bachelor's degree in engineering or science (such as pharmacy, microbiology, physics, and chemistry).
  • Bilingual English/Spanish - intermediate English level, reading and listening comprehension, writing, and oral expression.
  • Basic knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.).
  • Basic knowledge in root cause analysis tools.
  • Basic knowledge of process validation.
  • Knowledge of Six Sigma Methodology and Lean Manufacturing is a plus.
  • Knowledge of Minitab statistical software is a plus.
  • At least 1-year work experience in a manufacturing environment.
  • Project Management experience is a plus.


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