Medical Device Engineer II
hace 1 día
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.
- Prepare and maintain quality documents and records, including device master records and device history records.
- Review and approve documentation created by the manufacturing engineering department to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to analyze, review, and implement process improvements, new methodologies, and technologies to enhance manufacturing efficiency and product quality.
- Identify and investigate non-conformities, complaints, calibration, SCARs, and environmental monitoring issues, and implement corrective actions to prevent recurrence.
- 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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