Quality Systems Analytics Engineer

Position Summary

This position will perform data analytics for relevant quality management system processes to drive the strategy for Quality and Regulatory functions and support the overall growth of the business while driving regulatory compliance in a global market.

Position Qualifications

• Experience with advanced analytics tools and proven ability in using statistical analysis, predictive modeling, and explanatory modeling to analyze/interpret data and identify insights.
• Advanced level of understanding of data modeling, data management, and data visualization practices.
• Experience leveraging Microsoft Excel, PowerBI, SQL and Power Platform tools.
• Experience in working with Demand/Supply Planning Tools and ERP Systems.
• Excellent adaptive communication ability to a variety of audiences.
• The incumbent must also be a self-starter, be able to manage multiple priorities and possess the ability to drive root cause resolution.
• Knowledge of FDA and ISO guidelines is preferred.
• Demonstrated ability to root cause, solve problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change in collaboration with the QARA leadership team.
• High attention to detail and efficiency with excellent organizational skills.
• Level Of Experience: The ideal candidate will have 5-7 years of experience in an analytical role or technical role.
• Level Of Education: Bachelor’s degree required in Mechanical, Biomedical, Industrial, Manufacturing, or related Engineering discipline. Advanced coursework or experience in data analytics, supply chain, or process improvement preferred.

Essential Duties And Responsibilities

• Execute proof of concepts, pilots, special projects, and strategic collaboration in alignment with the leadership team.
• Owes the assessment, development, validation, and continued support of quality tools for assurance of data integrity that will be used in management of the QMS and organizational decisions and communication.
• Demonstrates strong root cause and problem solving of quality system tools and areas of focus for continuous improvement.
• Oversee the design, development, and maintenance of QA Analytics Solutions to ensure adherence to standards, guidelines, and best practices by all users.
• Apply advanced analytics tools to analyze data and create statistical or predictive models and algorithms.
• Create and maintain reports, dashboards, and visualizations to communicate data analysis results and recommendations.
• Conduct data collection, data mining, analysis, and reporting on ad hoc and recurring basis to monitor compliance and identify potential issues.
• Communicate analytical results in both a written and presentation format to executive leadership.
• Participate in continuous improvement efforts specific to quality data and analytics.
• Lead communication within RAQA to drive focus and prioritization of continuous improvement initiatives.
• Prepare weekly and monthly metrics for Quality Management Reviews and Operational Reviews such as trend charts, Pareto Analysis, as required under the guidance of the area manager.
• Compile product and site-specific trending data and metrics as requested.
• Support internal and external audits and inspections.
• Successfully execute reporting and analytics.
• Uses analytics to help drive the RAQA strategy and overall growth of the business.
• Collaboration with cross functional departments to ensure alignment of data.
• Maintenance of data sources with IT and System providers to ensure data integrity.

Quality Policy

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA Statement

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.