Senior Engineer Post Market Quality

Work Flexibility: Hybrid **What you will do:** * Partner with operations, business functions, and cross-functional teams to ensure high-quality product performance and continuous process improvement. * Engage with customers, sales, marketing, and field personnel to address top quality issues and drive resolution. * Mentor and provide oversight in NC/CAPA processes, leading root cause investigations and corrective actions. * Lead improvements in manufacturing processes, oversee concessions, and ensure robust change management practices. * Act as a subject matter expert in risk management, human factors, and regulatory compliance, supporting audits and validation strategies. * Analyze KPI trends, drive process enhancements, and optimize inspection methods and sampling strategies. * Support plant transfers, lead quality activities, and manage product holds for potential escapes. * Provide technical guidance and promote quality best practices across the organization. **What you need:** Basic Qualifications : * Bachelor's degree in a science or engineering related discipline * Minimum of 4+ years’ of experience in a regulated environment, adhering to GDP and GMP standards. * Expertise in Quality Concepts, including Risk Management, CAPA, Audits, and Statistical Analysis, to drive process improvements and compliance. Preferred Qualifications : * Utilized advanced statistical methods to analyze data, drive decision-making, and improve quality processes. * Leveraged Power BI to analyze and visualize data from Excel, providing actionable insights for decision-making. * Applied knowledge of SiMD/SaMD to support software-driven medical device processes and regulatory compliance. * Experienced in engaging with regulatory agencies (FDA, MoH, TUV) and ensuring compliance with U.S. and international medical device regulations. * Managed post-market quality processes, including compliance monitoring, risk assessment, and continuous improvement initiatives. Travel Percentage: 10%