Quality Engineer

Primary Job Title : Quality Engineer

Alternate / Related Job Titles :

Test Method Validation Engineer

Quality Assurance Engineer

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 per hour

Shift / Hours : Monday-Friday

8 : 30 AM - 5 : 00 PM

Job Summary :

The Quality Engineer will support Test Method Validation Remediation efforts and ensure that all test methods and validation documentation comply with FDA, ISO 13485, and regulatory standards. This position involves improving validation processes, implementing remediation plans, and maintaining compliance with quality and documentation requirements.

Key Responsibilities :

Support Test Method Validation (TMV) Remediation by reviewing and improving existing documentation.

Implement remediation plans to ensure all test methods meet current regulatory and quality standards.

Ensure validation records comply with FDA, ISO 13485, and company policies.

Maintain accurate and organized documentation of validation and remediation activities.

Perform inspections and quality assurance testing on raw materials, in-process materials, and finished products.

Set up and execute testing models and analysis procedures to ensure compliance and consistency.

Follow established processes and rely on standard work instructions and guidelines to perform duties efficiently.

Collaborate with cross-functional teams to maintain alignment with quality, manufacturing, and engineering functions.

Required Experience :

Bachelor's degree in Engineering, Quality Assurance, or a related field.

3-5 years of experience in test method validation or a related quality assurance discipline.

Hands-on experience with FDA-regulated environments and ISO 13485 quality systems.

Nice-to-Have Experience :

Experience in medical device manufacturing or regulated product development.

Exposure to remediation projects or compliance audits.

Experience authoring and reviewing validation protocols and reports.

Required Skills :

Strong knowledge of test method validation (TMV) and quality documentation standards.

Proficiency in technical writing and documentation accuracy.

Ability to work under supervision while maintaining high-quality output.

Preferred Skills :

Understanding of GMP and GLP principles.

Familiarity with CAPA, risk management, and process validation.

Analytical and problem-solving abilities with attention to detail.

Additional Skills :

Basic knowledge of inspection techniques and QA testing models.

Ability to interpret standard procedures and quality specifications.

Effective written and verbal communication across technical teams.

Benefits :

Medical, Vision, and Dental Insurance Plans

401k Retirement Fund

About the Client :

Innovative medical technology company empowering healthier lives. Focuses on women's health and well-being by providing products that detect, diagnose, and treat illnesses earlier. Driven by talented employees and a commitment to science-based solutions, the organization continues to advance healthcare innovation.

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 US and Canada. We look forward to helping you land your next great career opportunity!

Job Number : 25-27032 #gttic #gttjobs