Principal Quality Engineer in Marlborough

The 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, 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.

Qualifications

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

Skills & Competencies

Core 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

A 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.

GTT 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.