Quality Engineer

Salary Range: $ To $ Annually

POSITION SUMMARY:

The Quality Engineer ensures that radiopharmaceutical products and manufacturing processes comply with cGMP, regulatory requirements, and internal quality standards. They support process validation, equipment qualification, and troubleshooting to maintain consistent product quality. The role involves collaborating with Manufacturing, MSAT, and QA teams to investigate deviations, implement corrective and preventive actions (CAPA), and drive continuous improvement. The Quality Engineer will also review documentation, support audits, and contribute to regulatory submissions.

Strong attention to detail, problem-solving skills, and knowledge of pharmaceutical quality systems are essential to ensure safe and compliant production.

• Develop, implement, and maintain quality assurance procedures, processes, and documentation in compliance with relevant industry regulations and standards (e.g., FDA, ISO 13485, GMP).
• Conduct internal and external audits to identify areas for improvement and ensure adherence to quality standards and procedures.
• Participate in the management of the QMS, including document control, training, and record-keeping.
• Support regulatory inspections by the FDA and other foreign regulatory agencies.
• Provide quality oversight and support for the design and development of new radiopharmaceutical products, ensuring compliance with design controls and risk management principles.
• Review and approve project documents, design inputs, verification, and validation protocols and reports.
• Develop and execute validation activities for manufacturing processes, equipment, and testing methodologies.
• Collaborate with manufacturing teams to implement and maintain quality control measures on the production floor.
• Investigate and address quality issues, non-conformities, and deviations identified during manufacturing.
• Lead investigations into quality issues, customer complaints, and non-conformities to identify root causes using systematic problem-solving methodologies.
• Develop, implement, and monitor effective CAPAs to address identified issues, ensuring timely completion and verification of effectiveness.
• Track and trend quality data to identify recurring issues and opportunities for improvement.
• Collaborate with the purchasing and supply chain departments to qualify and manage suppliers based on their quality management capabilities.
• Conduct supplier audits and establish quality agreements to ensure compliance with company standards.
• Review and approve incoming materials and supplier documentation.
• Author, review, and approve regulated documents, including standard operating procedures (SOPs), test protocols, and reports.
• Develop and deliver training programs on quality assurance principles, regulatory requirements, and good manufacturing practices (GMP) for all relevant personnel.
• Maintain accurate and traceable records of all quality processes, procedures, and activities.
• Manage end-to-end process validation, improvements, and eventual decommissioning.
• Ensure compliance with global regulations (21 CFR 210/211/212, USP , EU GMP Annex 1/3, NRC, DOT Class
  7).
• Serve as SME during inspections and regulatory interactions.
• Select, commission, and validate radio synthesis platforms, hot cells, and automation systems, support training on new technologies.
• Oversee transfer documentation (URS, pRA, PQ) and deploy MES/e , LIMS, and quality-by-design solutions for data integrity and review-by-exception.
• Implement digital analytics to increase transparency and manufacturing efficiency.
• Develop dual-source isotope supply strategies (e.g., Lu-177, Ac-225) and ensure vendor qualification.
• Oversee cold-chain logistics and DOT-compliant radiopharmaceutical transport.
• Partner with Supply Chain to secure consumables, spare parts, and critical materials.
• Collaborate with QA on investigations, CAPA, deviations, and root-cause analysis.
• Apply ICH Q9 risk management to proactively address compliance and operational challenges.
• Drive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality.
• Develop and deliver training…