Title: Sr. Quality Engineer

Duration: 06 Months of contract (potential to conversion)

Location: 445 Simarano Drive, Marlborough, MA 01752

Payrate: $44/hr.-$46/hr. on W2

Shift: 8:30 am - 5 pm; Mon - Fri

:

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.

Documentation and Compliance:

Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements. Maintains accurate and organized records of validation activities.

Knowledge and Skills:

Familiar with commonly used concepts, practices, and procedures in test method validation. Proficiency in technical writing and documentation.

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.

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.