Quality Engineer

Job Description

Job Description

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

Company Description

Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.

We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.

There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers

Awards

SIA’s Fastest Growing Staffing Firm : 2023 and 2015

SIA’s Best Staffing Firm to Work for : 2019 -2023

Inc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015

Randstad Preferred Supplier : 2020 - 2023

TechServe Alliance Excellence Award. 2019

NH Business Magazines Fast 5 fastest growing companies

Ernst & Young Entrepreneur of the Year Finalist : 2015

Company Description

Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm : 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for : 2019 -2023\r\nInc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier : 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist : 2015