Global Technical Talent, an Inc. 5000 Company · 14 hours ago
Principal Quality Engineer
Marlborough, MA
Contract
Onsite
Lead/Staff
$69.71/hr - $69.71/hr
8+ years expGlobal Technical Talent is a leading provider of diagnostic information services, empowering healthier lives through data-driven insights. The Principal Quality Engineer - Pharma and Diagnostics ensures that in vitro diagnostic (IVD) products meet stringent regulatory and quality requirements throughout the product lifecycle, leading quality engineering initiatives and driving continuous improvement across the Quality Management System (QMS).
CRMHuman ResourcesInformation TechnologyStaffing Agency
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
Qualification
Required
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
Benefits
Medical, Vision, and Dental Insurance Plans
401(k) Retirement Fund
Company
Global Technical Talent, an Inc. 5000 Company
Global Technical Talent (GTT) is a leading provider of Total Talent Solutions and a proud subsidiary of Chenega Corporation(www.chenega.com), a Native American corporation with over $1.5 billion in revenue and 7,200 U.S.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Mario Moussa
Director of Strategic Partnerships
Company data provided by crunchbase