Quality Systems Analytics Engineer

AirLife; Grand Rapids (MI); On-site; USD 80,000 - 100,000; Full time

Job summary

AirLife, based in Grand Rapids, Michigan, seeks a Data Analytics professional to enhance Quality and Regulatory functions. This role involves leveraging advanced analytics to drive regulatory compliance and improve patient safety. The ideal candidate should have 5-7 years of relevant experience and a bachelor's degree in engineering.

Responsibilities include developing QA analytics solutions, conducting data analysis, and collaborating across departments. A focus on precision, customer experience, and safety is critical in this dynamic environment.

Qualifications

• 5-7 years of experience in an analytical or technical role.
• Knowledge of FDA and ISO guidelines preferred.
• High attention to detail and efficiency with excellent organizational skills.

Responsibilities

• Execute proof of concepts and strategic collaboration.
• Oversee development of QA Analytics Solutions.
• Communicate analytical results to executive leadership.

Skills

Advanced analytics tools

Statistical analysis

Predictive modeling

Data visualization practices

Microsoft Excel

PowerBI

SQL

ERP Systems

Adaptive communication

Root cause analysis

Education

Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering

Tools

Power Platform tools

Demand/Supply Planning Tools

Job description

Overview

AirLife is a premier manufacturer of breathing consumables, focused on improving the quality of every breath. We emphasize a mindset to evolve, innovate, and grow, with a global footprint and a product portfolio spanning care from first responder to home care. Our values include Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability.

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

Position Qualifications

Knowledge, Skills, & Abilities:

• 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 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.
• Self-starter, able to manage multiple priorities and drive root cause resolution.
• Knowledge of FDA and ISO guidelines is preferred.
• Demonstrated ability to root cause, solve problems, identify opportunities, collect data, analyze 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 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.

Travel:

• Up to 15% travel may be required, as needed.

Essential Duties And 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.
• Use analytics to help drive the RAQA strategy and overall growth of the business.
• Collaborate with cross-functional departments to ensure alignment of data.
• Maintenance of data sources with IT and System providers to ensure data integrity.

Other Responsibilities

• 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.

Policies

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.

Note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.