Medical Device Engineer II

hace 1 día


San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo
Job Description:
Viant Medical is a dynamic and innovative company that designs, develops, and manufactures Class II medical devices. We are looking for a highly motivated and experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products, from design to delivery.

  1. Prepare and maintain quality documents and records, including device master records and device history records.
  2. Review and approve documentation created by the manufacturing engineering department to ensure compliance with regulatory requirements.
  3. Collaborate with cross-functional teams to analyze, review, and implement process improvements, new methodologies, and technologies to enhance manufacturing efficiency and product quality.
  4. Identify and investigate non-conformities, complaints, calibration, SCARs, and environmental monitoring issues, and implement corrective actions to prevent recurrence.
  5. Support project management activities, including preparation of reports, protocols, and procedures.

Requirements:
- Bachelor's degree in engineering or science
- Bilingual English/Spanish - intermediate level of reading and listening comprehension, writing, and oral expression
- Basic knowledge of applicable regulations for the medical device industry (FDA, ISO)
- Basic knowledge of root cause analysis tools and process validation
- Knowledge of Six Sigma methodology and Lean Manufacturing is a plus

About Viant Medical:
Viant Medical is a leading manufacturer of Class II medical devices. Our mission is to provide high-quality products and services to our customers while ensuring the safety and efficacy of our devices. We are committed to innovation, collaboration, and excellence in everything we do.

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