Senior Quality Engineer

What You Will Do-

• Understanding of end-to-end complaint lifecycle
• Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations
• Author and peer review Post market plans/reports on JR products sold worldwide.
• Provide technical expertise in data analysis, data preparation and performance monitoring
• Build, manage and maintain reports, dashboards and visualizations as needed
• Communicate key findings to business partners and leadership throughout the organization
• Help develop automated solutions for dashboard and report generation
• Generate and analyze metrics and make recommendations as required
• Generate data for Competent Authorities (FDA, BSI and other regulatory bodies).
  

Required-

What you need-

• Experience on Post Market Surveillance as per US FDA & EU MDR; Quality Management (ISO 13485 or 21 CFR 820) and experience with TrackWise and Microsoft Project
• Minimum 4-7 years of experience in Medical Device domain
• Understanding on Medical Device Risk Management
• Strong Analytical and Statistical Skills (proficient in Advance Excel, Power BI. Tableu, Minitab)
  

Preferred-

• Ability to influence and motivate the cross functional team.
• Project management experience and experience to lead & achieve global process improvement efforts.
• Experience of working with multiple teams and collaborating across geographically spread multi-functional teams
• Strong interpersonal skills & communications skills