Quality Systems Analytics Engineer

Job Description

Job Description

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

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 thru the use of the 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 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.

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
• 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.

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.

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.

Please 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.