Quality Enterprise Systems Analyst

Requisition ID:6743

Job Title:Quality Enterprise Systems 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 Enterprise Systems Analyst responsible for owning and enhancing in key continuous improvement initiatives related to Quality Enterprise System and related processes, with a primary focus on Corrective and Preventive Actions (CAPA), nonconforming product management, complaint handling and post market surveillance, product specifications, and change management. This role serves as the enterprise system liaison for one or more quality system elements, ensuring these processes are aligned with the enterprise software system implementation. As an Quality Enterprise Systems Analyst, this role will be responsible for applying GAMP5 and Computer Systems Validation (CSV) principles for process enhancement, streamlining, automation, and reporting.

The Quality Enterprise Systems Analyst operates as a key contributor within the Quality Assurance organization, influencing both strategic initiatives and day-to-day operations across multiple departments. The Quality Enterprise Systems Analyst works with business process owners to drive streamlining, automation, and validation of processes, owning the results of those initiatives. This role requires cross-functional collaboration with manufacturing, engineering, regulatory, supplier quality, and supply chain teams to ensure the effective implementation and maintenance of assigned quality system elements. As a business process liaison, the Quality Enterprise Systems Analyst ensures compliance with internal procedures and external regulatory requirements and all applicable standards, while driving continuous improvement in Corrective and Preventive Actions (CAPA), nonconforming product management, complaint handling and post market surveillance, product specifications, and change management. The position demands both technical acumen and strong communication skills to align quality system practices with organizational goals and regulatory standards. This process also requires project leadership communication skills, such as management of stakeholders and aligning communications and reporting to their expectations.

Key Responsibilities:

• Be a liaison to business process owners to enhance processes, ensure alignment with regulatory requirements, and implement strategic automation.
• Lead and coordinate software-related 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.
• Design and apply processes implementing GAMP 5 risk-based principles to ensure computerized systems are fit for intended use and compliant with regulatory requirements.
• Oversee process communications, such as status reporting, project timeline management, resource load, and assurance of quality throughout projects.
• Maintain and improve documentation and records related to quality system processes, particularly those related to critical ongoing projects.
• Own and participate in key quality systems projects, maintaining stakeholder communication, project documentation, and reporting on project success.
• Collaborate with cross-functional teams to support post-market surveillance processes and drive related quality improvements.
• Support change management efforts for processes and existing product lines.
• Conduct quality data analysis to identify trends, assess process 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
• Product Supply
• Global Packaging

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, Life Sciences, or a related field required.
• 3+ years of experience in a quality engineering or quality systems role in a regulated industry (medical device, pharma, biotech, etc.).
• Experience with Computerized System Validation (CSV) requirements, implementation, and best practices.
• Strong understanding of the role of data-driven decision making 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.
• Proficient in Microsoft Office and quality system management tools/software (e.g., TrackWise, MasterControl, Veeva, ETQ).
• Working knowledge of computerized system validation best practices (GAMP5).
• Lean Six Sigma certification or experience with continuous improvement methodologies.

Preferred:

• Master's degree in engineering, Life Sciences, or a related field.
• 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)
• Experience applying ALCOA+ principles to process automation and software.
• Experience with root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree).
• Familiarity with document control, risk management, and product lifecycle requirements.
• 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.
• Understanding of project and process reporting structures, communications planning, and Quality project management best practices.
• Experience supporting internal or external audits and regulatory inspections

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, pleaseapply 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