Research Associate, Quality Engineering, Regulatory Compliance Specialist

Elutia is seeking a hands-on Process Quality Engineer to drive quality activities supporting the transfer, scale-up, and commercial manufacture of innovative drug-eluting biological products in a small, fast-paced environment.

This role will partner closely with Operations and R&D to help translate development processes into robust, controlled, and scalable manufacturing processes. The Process Quality Engineer will support process characterization, design and execute process studies, evaluate manufacturing changes, troubleshoot process issues, and apply sound risk-based Quality judgment to ensure appropriate controls are established and maintained.

The role will also support execution and continuous improvement of Quality Management System processes, including change control, nonconformance and deviation management, CAPA, document control, supplier quality, and audits.

Process Quality Engineering & Scale-Up

• Partner with Operations and R&D to support development, scale-up, transfer, and implementation of manufacturing processes.
• Provide Quality Engineering input to process optimization, characterization, scale-up, technology transfer, and commercialization activities.
• Help identify critical process parameters, sources of variability, and process controls.
• Contribute to technically sound and appropriately scoped studies to evaluate process variables, equipment, materials, manufacturing changes, and scale-up risks.
• Support equipment and process qualification and validation, including IQ/OQ/PQ activities.
• Apply appropriate statistical and risk-based approaches to process characterization, validation, and manufacturing data.
• Evaluate process performance and variability and identify opportunities to improve process capability, strengthen process control, and reduce manufacturing
• costs.
• Provide hands-on Quality support on the manufacturing floor during scale-up, process changes, validation activities, investigations, and troubleshooting.

Change Implementation & Problem Solving

• Lead change controls from technical evaluation through implementation and effectiveness assessment.
• Lead nonconformance investigations, deviations, CAPAs, and root-cause investigations.
• Work collaboratively with technical teams to identify effective corrective and preventive actions that address root causes and are appropriate to the level of risk.
• Apply sound, risk-based Quality judgment to determine the appropriate level of testing, controls, documentation, and escalation.

Quality Systems Support

• Support execution and continuous improvement of Quality Management System processes, including change control, CAPA, nonconformance and deviation management, document control, training, supplier quality, validation, and risk management.
• Support internal and external audits, including preparation, response development, and follow-up actions.
• Author, revise, and review procedures, protocols, reports, specifications, and other controlled documents.
• Help maintain compliant and effective records and training associated with manufacturing and Quality activities.
• Partner with functional owners to ensure Quality System activities are completed accurately and on time.
• Contribute to updates of procedures and Quality System processes to support compliant and efficient operations.

• Bachelor’s degree in engineering, science, or a related technical discipline.
• 5+ years of Quality Engineering, Process Engineering, Manufacturing Engineering, or closely related experience in medical devices, pharmaceuticals, or another highly regulated field.
• Demonstrated experience supporting manufacturing process development, scale-up, characterization, or process validation.
• Experience with change control, investigations, nonconformances, CAPA, and risk management.
• Working knowledge of FDA Quality System requirements/QMSR and ISO 13485.
• Strong problem-solving skills and ability to independently drive work to completion in a fast-paced environment with competing priorities.

Guided by purpose, trust, and inclusion, Elutia is proud to be an equal opportunity employer.