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%