Senior Engineer, Post Market Quality

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 :

• Bachelors 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.