Quality Assurance Specialist

hace 3 días


San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo
Company Overview:
Viant Medical is a leading manufacturer of Class II medical devices. We are committed to providing high-quality products and services to our customers while ensuring the safety and efficacy of our devices.

Job Summary:
We are seeking an experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest quality standards. 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
- Execute reviews and approvals of documentation created by the manufacturing engineering department
- Support analysis, review, and implementation of new methodologies and processes to improve manufacturing efficiency and quality
- Check and initiate non-conformities, complaints, calibration, SCARs, and environmental monitoring
- Perform other duties and tasks as directed by the immediate supervisor or teammates

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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