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The Senior Quality Engineer is responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and Cytiva standards. This position reports to the Sr Manager, Site Quality and is part of the quality team located in Duncan, SC and will be an on-site role.
Job Responsibility:
Maintain and implement Standard Operating procedures, process flow charts, Process Control Plans, Process FMEA, change controls, and validations
Lead or support site level projects and initiatives ensuring Quality Assurance priorities are fully integrated in operational strategies, and regulatory compliance is maintained
Partner with cross-functional stakeholders to support expansion, risk mitigation and productivity while ensuring product quality
Manage Non-conformance, CAPA and Complaint processes
perform root cause analysis and implement robust corrective actions
Verify effectiveness to prevent recurrence and ensure timely closure
Provide manufacturing quality trend analysis and recommend improvements
Support Kaizen and Shin Kaizen events using Lean manufacturing principles, and Danaher Business System tools to drive continuous improvements
Requirements:
Bachelor’s degree in engineering (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) or equivalent work experience
Experienced in managing quality workflows, including qualification, auditing, change management, CAPA resolution, deviations, and QMS development
Strong interpersonal and communication skills to implement and execute strategies that ensure compliance with regulatory and industry standards
Nice to have:
Strong problem solving, and root-cause analysis skills with the ability to influence others to drive change (cross-functionally and globally)
Experience with electronic QMS platforms (VEEVA, Magic) and SAP Inventory Management preferred