What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
Responsibilities
- Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
- Requires a bachelor's degree and 02 years of experience in the field or in a related area.
- Has knowledge of commonly used concepts, practices, and procedures within a particular field.
- Relies on instructions and preestablished guidelines to perform the functions of the job.
- Works under immediate supervision.
- Primary job functions do not typically require exercising independent judgment.
- Typically reports to a supervisor or manager.
- Relies on instructions and pre-established guidelines to perform job functions.
- Works under immediate supervision, with primary job functions not typically requiring independent judgment.
- Reports to a supervisor or manager.
- Assists in the review and improvement of existing test method validation documentation .
- Supports Test Method Validation Remediation .
- Implements remediation plans to ensure test methods comply with current regulatory standards.
- Requires a bachelor's degree in engineering, Quality Assurance, or a related field .
- Required # of years' experience: 3 - 5 years.
- Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.
- Maintains accurate and organized records of validation activities.
- Familiar with commonly used concepts, practices, and procedures in test method validation.
- Proficiency in technical writing and documentation.
