Job Description
Job Description
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
Job Description:
- 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.