Quality Systems Analytics Engineer

AirLife•Grand Rapids, MI

2d•Onsite

About The Position

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. This role is expected to lead and influence the organization, with focus and prioritization to improve patient safety, customer experience, and regulatory compliance thru the use of the quality driven metrics and data.

Requirements

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.
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.

Nice To Haves

Knowledge of FDA and ISO guidelines is preferred.
Advanced coursework or experience in data analytics, supply chain, or process improvement preferred.

Responsibilities

Execute proof of concepts, pilots, special projects, and strategic collaboration in alignment with the leadership team.
Owns 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.
Uphold and embody AirLife’s values in all aspects of work.
Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
Contribute to building and maintaining a positive team environment.
Assure all policies and guidelines are implemented and followed.