Job Description
Job DescriptionPrimary Job TitlePrincipal Quality Engineer – Pharma and Diagnostics
Alternate / Related Job Titles
- Principal Quality Engineer – IVD
- Senior Quality Engineer – Diagnostics
- Quality Engineering Lead – Medical Devices
- Quality Systems Engineer – IVD
Location & Onsite FlexibilityMarlborough, MA
OnsiteContract Details
Position Type: Contract
Contract Duration: 12 months
Start: As Soon As Possible
Pay Rate: $69.71/hour
Shift: 1st Shift, Monday–Friday (8:00 AM – 5:00 PM EST)Job SummaryThe Principal Quality Engineer – Pharma and Diagnostics ensures that in vitro diagnostic (IVD) products meet stringent regulatory and quality requirements throughout the product lifecycle. This role leads quality engineering initiatives, supports product development and manufacturing activities, and drives continuous improvement across the Quality Management System (QMS).The ideal candidate brings deep expertise in design controls, risk management, and global regulatory compliance within FDA- and ISO-regulated environments.Key Responsibilities
- Develop, implement, and maintain quality systems and processes in compliance with FDA 21 CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971, and related regulations.
- Conduct hazard analyses and risk assessments throughout the IVD product lifecycle in accordance with ISO 14971.
- Lead internal and external audits, including preparation, execution, and follow-up.
- Oversee CAPA, non-conformance investigations, and deviation management.
- Collaborate with cross-functional teams to integrate quality requirements into product design, verification, and validation activities.
- Review and approve design control documentation, including design inputs/outputs, V&V protocols and reports, and risk management files.
- Assess, qualify, and manage suppliers throughout product development and lifecycle.
- Establish and maintain Design History Files (DHF) for IVD products.
- Monitor and analyze quality metrics, trends, and performance data to drive improvement.
- Support regulatory submissions and product approval activities.
- Manage complaints, post-market surveillance, field actions, MDRs, EU incident reporting, and failure trending.
- Maintain current knowledge of laboratory and diagnostic regulatory requirements.
- Drive continuous improvement initiatives leveraging audit feedback, post-market data, and industry best practices.
- Update internal procedures, policies, and training materials as regulations evolve.
- Perform other duties as assigned.
QualificationsRequired
- Bachelor’s degree (required)
- 8+ years of experience in Medical Devices and/or IVD design and development
- Strong expertise in design controls and risk management
- Proven experience with QMS development and regulatory compliance
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills
Preferred
- Experience working in an FDA-regulated environment
- Hands-on experience with IVD products
- Experience applying regulations such as IEC 62304, FDA 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA
- ASQ Certification preferred
- Regulatory Affairs Certification (RAC) preferred
Skills & CompetenciesCore Skills
- Quality management systems & regulatory compliance
- Design controls & risk management
- Audit leadership & CAPA management
- Analytical problem-solving and decision-making
- Cross-functional collaboration and influence
Competencies
- Ability to influence change and drive results
- Strong interpersonal and presentation skills
- Excellent technical writing and documentation skills
- Proven ability to motivate teams and lead in matrixed environments
Work Environment
- Prolonged sitting and computer-based work
- Occasional work within laboratory environments; PPE required as appropriate
- Frequent electronic communications (email/text)
- Possible travel by air, train, or car
- Ability to understand and apply written and verbal instructions
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401(k) Retirement Fund
About the CompanyA leading provider of diagnostic information services, empowering healthier lives through data-driven insights. Leveraging one of the world’s largest clinical laboratory databases, the organization supports disease identification, treatment, and improved healthcare outcomes globally.About GTTGTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company based in Alaska. We highly value diverse and inclusive workplaces and partner with Fortune 500 organizations across banking, insurance, financial services, technology, life sciences, biotech, utilities, and retail throughout the U.S. and Canada.Job Number: 26-00811
#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