Senior Quality Engineer - Post Market

Job description

Work Flexibility: Hybrid What you will do - you will be responsible for monitoring the safety and performance of Joint Replacement products. You will employ various statistical tools and methodologies to analyze post market data, develop metrics and communicate any conclusions with business partners such as Design Assurance, Regulatory Affairs and Product Development. Author and ensure on time completion of PSUR report from scoping to completion on JR products. Evaluate safety data and signals as a part of ongoing pharmacovigilance activities. Lead and support identification of trends and patterns and interpretation of data in safety assessment and evaluation Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations Provide technical expertise in data analysis, data preparation and performance monitoring Communicate key findings to business partners and leadership throughout the organization Build, manage and maintain reports, dashboards and visualizations as needed. Help develop automated solutions for dashboard and report generation What you will need- Required skills- Bachelor's Degree in Engineering, Statistics or a related field experience- 3 years - 6 years Previous work experience in a regulated environment required Excellent documentation and communication skills. Preferred skills- Good analytical and problem-solving skills. Experience with Microsoft Power BI preferred Proficient computer skills in advance excel and word. Understanding of databases and data warehouses preferred Prior experience using complaints processing software (good to have) Travel Percentage: None