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%