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Quality Systems Data Analyst
Quality Systems Data AnalystAvanos Medical • Alpharetta, GA, US
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Quality Systems Data Analyst

Quality Systems Data Analyst

Avanos Medical • Alpharetta, GA, US
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Requisition ID :  6744

Job Title :  Quality Systems Data Analyst

Job Country :  United States (US)

Here at Avanos Medical, we passionately believe in three things :

  • Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
  • Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
  • Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com .

Essential Duties and Responsibilities :

The Quality Systems Data Analyst owns the data pipeline for the Quality Management System. They are responsible for developing, automating, executing, and maintaining Quality Systems data reports, including those for Quality Performance Metrics, Global Post-Market Surveillance, Quality System processes, and those related to nonconformity or Corrective and Preventive Action (CAPA) investigations. This role collaborates with business process owners for quality system elements, ensuring data accurately represents these processes are such that they can be monitored and continuously improved. The Quality Systems Data Analyst also plays a critical role in driving data-driven improvements and enhancing overall product and process quality. In performing this work, the Quality Systems Data Analyst is responsible for designing and implementing data automation pipelines, following GAMP5 and CSV principles, and ensuring that internal process owners have readily available, validated data for making key Quality decisions.

The Quality Systems Data Analyst operates as a key contributor within the Quality Assurance organization, influencing both strategic initiatives and day-to-day operations across multiple departments. This role requires cross-functional collaboration with manufacturing, engineering, regulatory, and supply chain teams to ensure the effective implementation and maintenance of assigned quality system elements. In working with business process owners, the Quality Systems Data Analyst ensures compliance with internal procedures and external regulatory requirements, while driving continuous improvement in CAPA, nonconformance handling, product specifications, and sustainability change management processes. The position demands both technical acumen and strong communication skills to align quality system practices with organizational goals and regulatory standards.

Key Responsibilities :

  • Support sustaining Quality Systems and Continuous Improvement (CI) activities.
  • Pull, validate, and publish data for Quality KPIs and process metrics.
  • Develop, automate, and maintain dashboards and data pipelines for Quality.
  • Extract and parse data from the eQMS and related systems (e.g., ERP / LIMS / complaints) to build reliable datasets.
  • Apply GAMP 5 risk-based principles to ensure computerized systems are fit for intended use and compliant with regulatory requirements.
  • Generate and distribute recurring and ad-hoc Quality and PMS reports.
  • Lead audit preparation data pulls, ensuring traceability and retention.
  • Maintain data integrity and documentation in a regulated (GxP) environment.
  • Provide analytical support to quality projects (e.g., CAPA effectiveness, complaint trending, risk signals).
  • Participate in root cause investigations and the implementation of effective corrective and preventive actions.
  • Ensure timely resolution of quality events in alignment with internal procedures and external regulatory requirements.
  • Maintain documentation and records related to quality system processes.
  • Collaborate with cross-functional teams to drive related quality improvements.
  • Analyze data to determine trends, effectiveness, and recommend improvements.
  • Participate in audits and inspections by providing documentation, records, and subject matter expertise for assigned areas.
  • Provide training and guidance to internal stakeholders on quality system processes and best practices.
  • Key Relationships / Customer Expectations

    This person interacts with the following roles :

  • Global Quality Systems
  • Global Health Care Compliance
  • R&D
  • IT
  • Technical Quality Leaders
  • Procurement Commodity Managers and Buyers
  • Operations Quality Managers
  • Global RA / QA
  • Key Leadership Behaviors

  • Acts with integrity and maintains high ethical standards.
  • Demonstrates strong decision-making and problem-solving capabilities.
  • Fosters collaboration and effective communication across all organizational levels.
  • Promotes continuous learning and professional development within the team.
  • Leads by example, demonstrating accountability and ownership.
  • Your qualifications

    Required :

  • Bachelor’s degree in engineering, Data Science, Life Sciences, or a related field.
  • 4+ years of experience in a quality engineering, quality systems, or an analytics role in a regulated industry (medical device, pharma, biotech, etc.).
  • Experience with Computerized System Validation (CSV) requirements, implementation, and best practices.
  • Proficiency with SQL and Excel, experience with BI tools (Power BI / Tableau / Looker), automation (Python / R / C#).
  • Proficient in Microsoft Office and quality system management tools / software (e.g., TrackWise, MasterControl, Veeva, ETQ).
  • Experience in applying data science principles for Post-Market Surveillance activities including data trending, data transformation, and statistical methods.
  • Preferred :

  • Master’s degree in engineering, Data Science, Life Sciences, or a related field.
  • Experience with Microsoft Fabric infrastructure including medallion-tiered data pipeline architecture, design, and management.
  • Strong knowledge of CAPA processes, nonconformance handling, and quality system regulations (e.g., 21 CFR 820 QSR and the FDA QMSR alignment with ISO 13485)
  • Strong understanding of the role of data analysis within Quality Systems processes, including post-market surveillance, nonconformance investigation, and KPI tracking and trending.
  • Understanding of ETQ Reliance eQMS components, data structures, database architecture, and development.
  • Understanding of differences between SQL languages, with specific experience with Microsoft SQL Server and SQL Server Management Studio.
  • Experience leveraging SaaS product API endpoints for programmatic data retrieval, including single and multiple record request parsing.
  • Experience with both REST-like and GraphQL API endpoint technologies, design patterns, and API consumption best practices.
  • Experience applying ALCOA+ principles to data retrieval and analysis pipelines.
  • Experience with root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree).
  • Familiarity with document control, risk management, and product lifecycle requirements per ISO 13485.
  • Experience applying GAMP 5 principles to ensure that computerized systems are fit for intended use, focusing on risk management, patient safety, product quality, and data integrity.
  • Excellent communication, organizational, and analytical skills
  • The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

    Salary Range :

    The anticipated average base pay range for this position is $83,000.00 - $94,000.00. In addition, this role is eligible for an attractive benefits package.

    Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please  apply here

    Join us at Avanos

    Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

    Make your career count

    Our commitment to improving the health and wellbeing of others begins with our employees – through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work / life benefits.

    Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

    Avanos also offers the following :

    benefits on day 1

    free onsite gym

    onsite cafeteria

    HQ region voted 'best place to live' by USA Today

    uncapped sales commissions

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