Quality Assurance Specialist

hace 2 meses


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

This is a challenging opportunity for an experienced Quality Assurance Specialist to join Viant Medical as a Process Validation Engineer II. In this role, you will provide critical support to the development and production of Class II Medical Devices, ensuring compliance with regulatory requirements.

Main Responsibilities
  • Prepare and update quality documents, including Device Master Records and Device History Records.
  • Execute reviewing and approval of documentation created by the Manufacturing Engineering department.
  • Analyze and implement new methodologies and processes to improve manufacturing efficiency and quality systems.
  • Support investigations and corrective actions for NCs, Complaints, Calibration, SCARs, and Environmental Monitoring.
  • Provide follow-up on actions generated from corrective and preventive plans.
Requirements
  • Bachelor's degree in engineering or science (e.g., 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).
  • At least 1-year work experience in manufacturing environment.
  • Project Management experience is a plus.

The estimated salary for this position is $80,000-$110,000 per year, depending on location and experience. If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply.



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