Senior Quality Engineer - Post Market

Overview

Senior Quality Engineer in Post Market, responsible for monitoring the safety and performance of Joint Replacement products using statistical analysis of post market data.

What you'll do

• Monitor the safety and performance of Joint Replacement products.
• Employ various statistical tools and methodologies to analyze post market data and develop metrics.
• Communicate conclusions with business partners such as Design Assurance, Regulatory Affairs and Product Development.
• Author and ensure on-time completion of PSUR reports from scoping to completion on JR products.
• Evaluate safety data and signals as 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 it 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'll need

• Bachelor's Degree in Engineering, Statistics or a related field.
• 3 to 6 years of experience.
• Previous work experience in a regulated environment.
• Excellent documentation and communication skills.

Nice to have

• Good analytical and problem-solving skills.
• Experience with Microsoft Power BI.
• Proficient computer skills in advanced Excel and Word.
• Understanding of databases and data warehouses.
• Prior experience using complaints processing software.

Details

• Work mode: Hybrid.
• Travel: None.