Demo

Quality Engineer II

Careers Integrated Resources Inc
Marlborough, MA Contractor
POSTED ON 4/3/2025
AVAILABLE BEFORE 5/2/2025
Title: Quality Engineer II

Duration: 6 months (Possibility of extension) 

Location: Marlborough, MA



Summary of Duties and 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 0-2 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 pre-established 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.



• Supports Test Method Validation Remediation:

- Assists in the review and improvement of existing test method validation documentation

-Implements remediation plans to ensure test methods comply with current regulatory standards.



• Documentation and Compliance:

-)Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.

-Maintains accurate and organized records of validation activities.



• Qualifications:

-Requires a bachelor's degree in Engineering, Quality Assurance, or a related field.

-3-5 years of experience in test method validation or a related area.



• Knowledge and Skills:

-Familiar with commonly used concepts, practices, and procedures in test method validation.

-Proficiency in technical writing and documentation.



• Work Guidelines:

-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.

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