Job Description
Job Description
Primary Job Title:
Quality Engineer
Alternate/Related Job Titles:
Manufacturing Quality Engineer
Medical Device Quality Engineer
Quality Assurance Engineer
Supplier & Manufacturing Quality Engineer
Regulatory Quality Engineer
Location:
Marlborough, MA
Onsite Flexibility:
Onsite
Contract Details (Contract roles only):
Job Summary:
The Quality Engineer 2 ensures medical device capital equipment manufacturing operations meet the highest quality standards by supporting manufacturing quality control and regulatory compliance. This role collaborates across teams to drive continuous improvement, maintain robust process controls, and deliver innovative solutions that support product quality, safety, and reliability.
Through integrity, operational excellence, and a customer-focused mindset, the Quality Engineer 2 contributes to organizational success by supporting manufacturing operations and ensuring compliance with regulatory and quality system requirements.
Key Responsibilities:
Support daily manufacturing quality operations, including nonconforming event (NCE) investigations, rework approvals, and equipment record reviews.
Lead NCE investigations to evaluate the impact of nonconforming materials on product quality and compliance.
Determine containment actions, perform root cause investigations, assess risks, and collaborate with cross-functional stakeholders.
Drive timely disposition, release activities, and resolution efforts aligned with regulatory and quality system requirements.
Monitor NCE data to identify trends and areas for improvement through data-driven decision making.
Initiate and drive corrective actions to address unfavorable trends and maintain product quality and compliance.
Assess equipment controls including validation, calibration, and preventative maintenance.
Conduct out-of-tolerance investigations and approve equipment records to ensure device manufacturing validity.
Support additional quality engineering activities including process validation, documentation review, and engineering collaboration.
Required Experience:
Bachelor’s Degree in Engineering or related discipline, or equivalent combination of education and experience.
2–4 years of experience as a Quality Professional in the Medical Device industry or related regulated industry.
Experience supporting manufacturing quality operations and compliance activities.
Experience performing root cause investigations and corrective actions.
Nice-to-Have Experience:
Experience with Class II or Class III medical devices and IVD device capital equipment.
Experience supporting New Product Introduction (NPI) and design transfer activities.
Experience with test method validation and process validation (IQ, OQ, PQ).
Required Skills:
Nonconforming event (NCE) investigation and root cause analysis
Quality systems and regulatory compliance
Manufacturing process quality support
Preferred Skills:
ISO 13485 and FDA regulatory compliance
Risk management and ISO 14971
CAPA management and quality investigations
Statistical analysis tools and Six Sigma methodologies
Equipment validation and calibration processes
Additional Skills:
Process FMEA development
Corrective and Preventive Actions (CAPA)
Test Method Validation (TMV)
Process Validation (IQ, OQ, PQ)
EU MDR / IVDR compliance
cGMP requirements
Statistical Process Control (SPC)
Design of Experiments (DOE)
Technical documentation and procedure review
Quality Management Systems (QMS)
Data analysis and enterprise systems usage
Good Documentation Practices (GDP)
Benefits:
About the Client:
Innovative medical technology company empowering healthier lives. Focuses on women's health and well-being. Offers products to detect, diagnose, and treat illnesses earlier. Driven by talented employees and a commitment to science-based solutions.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number:
26-02263
Hashtags:
#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