Job Description
Job DescriptionPrimary Job Title:
Quality EngineerAlternate/Related Job Titles:
- Supplier Quality Engineer
- Manufacturing Quality Engineer
- Process Quality Engineer
- Quality Assurance Engineer
Location:
Marlborough, MAOnsite Flexibility:
OnsiteContract Details:
- Position Type: Contract
- Contract Duration: 12 months
- Start: As Soon As Possible
- Pay Rate: $55/hour
Job SummaryThe Quality Engineer supports the Global Supplier Quality organization by ensuring compliance with regulatory and quality management standards for components, materials, and services. This role provides technical expertise to evaluate supplier capabilities, manage performance metrics, oversee audits, and support continuous improvement initiatives across the global supply chain. The engineer will also work closely with cross-functional teams—including R&D, Design Assurance, Manufacturing, and Post Market Surveillance—to maintain the highest standards of product safety and reliability.Key Responsibilities
- Execute all activities necessary to comply with Quality Management System (QMS) requirements and regulatory standards (FDA, ISO 13485, ISO 14971, ISO 9001).
- Conduct technical reviews of suppliers to evaluate capability, quality control, and manufacturing practices.
- Oversee supplier performance in process validation, corrective actions, and First Article Inspections.
- Define and approve PPAP (Production Part Approval Process) requirements for new and revised parts; ensure timely completion.
- Manage and track supplier corrective actions (SCARs, SACAs, NCEs) using Agile Quality systems.
- Collaborate with suppliers to perform root cause analysis and implement preventive measures.
- Support internal and external audits as a subject matter expert.
- Partner with Post Market Surveillance to resolve supplier-related complaints.
- Drive nonconformance resolution through containment, rework, or return-to-supplier processes.
- Maintain accurate supplier quality records, certifications, and key performance metrics.
- Lead or support supplier qualification, onboarding, and periodic review activities.
- Generate and present supplier performance reports to internal stakeholders.
- Coordinate and execute new supplier implementation activities aligned with new product introductions or transfers.
- Ensure regulatory compliance across all applicable markets (FDA, Canada, Brazil, Japan, etc.).
Required Qualifications
- Bachelor’s degree in Engineering (Mechanical, Electrical, Mechatronics, or related field).
- Minimum 2 years of professional experience in the medical device industry, focused on supplier or manufacturing quality.
- Strong understanding of cGMP, QSR (21 CFR 820), ISO 13485, and ISO 14971 standards.
- Proven experience with CAPA, root cause analysis, and process validation (IQ/OQ/PQ).
- Working knowledge of statistical process control (SPC) and quality measurement tools.
- Excellent written and verbal communication skills; able to interact across all levels of the organization.
- Proficiency in Microsoft Office, Agile PLM, and Minitab (desirable).
Preferred Skills
- ISO 13485 Lead Auditor certification.
- ASQ Supplier Quality Engineer certification (preferred).
- Knowledge of measurement system analysis (GR&R, AAA).
- Familiarity with risk management and validation processes.
- Experience with Project, Visio, and data analysis tools.
- Second language proficiency is a plus.
Physical Demands
- Ability to sit, stand, walk, kneel, or crouch as required.
- Exposure to mechanical parts and moderate noise in manufacturing environments.
- Must wear safety shoes in designated areas.
- Ability to travel domestically and internationally as needed.
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401(k) Retirement Fund
About the ClientAn innovative medical technology company dedicated to empowering healthier lives, with a focus on women’s health and well-being. The organization develops advanced diagnostic, detection, and treatment technologies designed to identify illnesses earlier and improve patient outcomes through science-based innovation and excellence.About GTTGTT 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 include Fortune 500 companies across industries throughout the U.S. and Canada. We look forward to helping you land your next great career opportunity!Job Number: 25-28174#LI-GTT #LI-Onsite #gttjobsCompany DescriptionGlobal 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