Quality Engineer - Paris, Kentucky - Onsite

• Implements tactical and operational quality assurance goals, focusing on ensuring compliance with quality standards and continuous improvement initiatives.
• Contributes to implementing new testing protocols, inspection processes, regulatory compliance measures, or operational quality assurance plans, such as refining defect detection methods, enhancing validation procedures, and optimizing corrective action workflows.
• Manages quality assurance projects and/or processes, such as overseeing supplier audits, coordinating process validation initiatives, and supporting product quality enhancements through statistical analysis and testing optimization.
• Works on problems and issues with a diverse scope where analysis of information requires evaluation of multiple factors, such as balancing production efficiency with defect reduction, troubleshooting inconsistencies in testing data, and adapting quality control measures to meet evolving industry standards.
• Derives solutions based on limited information and/or precedents, such as developing proactive defect prevention strategies, refining standard operating procedures to address recurring compliance challenges, and implementing root cause analysis methodologies to resolve complex manufacturing quality issues.
• Communicates with parties within and outside of the quality assurance function, including customers, vendors, and regulatory bodies, ensuring alignment on quality standards, addressing compliance concerns, and supporting the resolution of product-related inquiries.
• Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.

Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

Required