Device Validation Expert
hace 3 días
As a Quality Assurance Specialist at Viant Medical, you will be responsible for ensuring the quality and compliance of our Class II medical devices. You will work closely with our development and production teams to identify and implement process improvements, maintain compliance with regulatory requirements, and ensure the quality of our finished goods.
Key Responsibilities:
- Prepare and update quality documents and records, including device master records and device history records
- Review and approve documentation created by the manufacturing engineering department
- 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
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
Benefits:
Viant Medical offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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