Quality Engineer II

Job 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.

Skills:

• 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.

Education/Experience:

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