Principal Quality Engineer

Job Title

Principal Quality Engineer - Hybrid (12-month assignment, 3-4 days onsite)

Marlborough, MA 01752

Duration: 12 months (possible extension). Pay: $59.44/hr on W2. Shift: 1st shift, M-F 8-5 EST (onsite first 90 days, hybrid thereafter).

This role ensures that Quest Diagnostics’ IVD products meet stringent regulatory requirements and quality standards. The Principal Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.

• Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations.
• Conduct hazard analysis and risk assessments for IVD products according to ISO
  14971 throughout the product lifecycle.
• Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements.
• Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues.
• Collaborate with cross‑functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls.
• Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation.
• Assess and qualify new suppliers in product development and throughout the product lifecycle.
• Establish and maintain Design History File for IVD products.
• Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement.
• Support regulatory submissions and activities for IVD product approvals.
• Support complaints process (review, process, investigate, trend quality data, etc.) and post‑market incident activities.
• Manage post‑market incident activities, including field action, MDRs, EU incident decision/reporting, and field failure trending.
• Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
• Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post‑market surveillance data.
• Stay current with evolving regulatory requirements, standards, and industry trends.
• Proactively update internal processes, policies and procedures, and training materials as needed.
• Follow corporate policies and procedures.
• Perform other duties as assigned.

8+ years in medical device design and development with a strong focus on design control and risk management.

• Experience working effectively in an FDA‑regulated environment.
• Experience working with IVD products.
• Analytical mindset with attention to detail and a commitment to integrity, product safety, and quality.
• Demonstrated experience applying medical device regulations (e.g., IEC 62304, FDA 21 CFR Part 803, 806, 820, ISO 13485, ISO 14971, IVDR, CLIA).

• Quality management system development, Design Controls, and risk management.
• Effective verbal and written communication, ability to build and manage teams, influence others, and drive results.
• Strong interpersonal communication skills and writing composition skills.
• Excellent problem‑solving and project management abilities; proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to function in a matrix organization and adapt to continuously changing priorities.
• Understanding of quality and regulatory requirements and ability to apply them.
• Capability to handle prolonged sitting at a desk, moving within an office or laboratory, wearing PPE as appropriate, responding to text/email communications, and traveling as required.

Bachelor’s Degree in Biology (required).

• ASQ Certification preferred.
• Regulatory Affairs Certification (RAC) preferred.

Pride Global offers eligible…