Primary Job Title
Quality Engineer
Alternate/Related Job Titles
* Quality Assurance Engineer
* Validation Engineer
* Test Method Validation Specialist
Location
Marlborough, MA
Onsite Flexibility
Onsite
Contract Details
* Position Type: Contract
* Contract Duration: 6 months
* Start: As Soon As Possible
* Pay Rate: $44 – $46/hr
* Shift Hours: 8:30 AM – 5:00 PM
Job Summary
The Quality Engineer supports key quality and compliance initiatives with a strong focus on Test Method Validation (TMV) remediation. The role ensures documentation accuracy, regulatory alignment, and high‑quality testing processes to help maintain compliance with FDA, ISO 13485, and related standards. This position operates within a structured environment, following established procedures and collaborating closely with supervisors and quality teams.
Key Responsibilities
* Support Test Method Validation remediation activities, including reviewing and improving existing TMV documentation.
* Implement remediation plans ensuring all test methods meet current regulatory expectations.
* Ensure validation records comply with FDA, ISO 13485, and other relevant regulatory requirements.
* Maintain accurate, complete, and well‑organized documentation of validation activities.
* Perform inspections and establish quality assurance testing models for raw materials, in‑process materials, and finished goods.
* Apply commonly used concepts, practices, and procedures in test method validation.
* Follow instructions and pre‑established guidelines to ensure high‑quality, compliant output.
* Work under immediate supervision; primary duties typically do not require independent judgment.
* Report directly to a supervisor or manager.
Required Experience
* Bachelor’s degree in Engineering, Quality Assurance, or a related technical field.
* 3–5 years of experience in test method validation or a related discipline.
Nice‑to‑Have Experience
* Experience in documentation control or regulated quality environments.
* Exposure to FDA‑regulated medical device manufacturing.
* Potential for conversion for the right candidate.
Required Skills
* Technical writing & documentation proficiency
* Test method validation knowledge
* Familiarity with FDA and ISO 13485 requirements
Preferred Skills
* Strong attention to detail
* Ability to work under defined procedures and supervision
* Organizational and record‑keeping accuracy
* Experience analyzing quality testing data
* Solid understanding of quality assurance principles
Additional Skills
* Ability to follow pre‑established guidelines
* Handling inspections and QA testing workflows
* Understanding of commonly used quality concepts and practices
* Ability to work within structured quality systems
Benefits
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Client
Innovative medical technology company empowering healthier lives, with a focus on women’s health and well‑being. Develops science‑based solutions to help detect, diagnose, and treat illnesses earlier. Driven by talented employees and a commitment to improving global healthcare outcomes.
About GTT
GTT is a minority‑owned staffing firm and a subsidiary of Chenega Corporation, a Native American‑owned company in Alaska. As a Native American‑owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the U.S. and Canada. We look forward to helping you land your next great career opportunity!
Job Number
25-28494
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