Quality Engineer

Description

Shift Hours: 8:30am - 5:00pm
Location: Marlborough, MA
Full time conversion possible for the right candidate

 Notes: 

• 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.

Summary of Duties and Responsibilities:

• Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
• 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.