Quality Engineer II

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.

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. 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. 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.

Requires a bachelor’s degree in engineering, Quality Assurance, or a related field. Required # of years’ experience: 3 - 5 years