Senior Quality Systems Engineer

Job Description

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Requisition ID: 7063

Job Title: Senior Quality Systems Engineer

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 Senior Quality Systems Engineer - CAPA & Compliance is responsible for leading and maintaining the effectiveness of the Corrective and Preventive Action (CAPA) system and ensuring ongoing compliance with applicable global regulatory requirements and quality standards. This role plays a critical part in driving continuous improvement, ensuring robust root cause analysis, and maintaining audit readiness across the organization.

Key Responsibilities:

CAPA Management

• Act as a subject matter expert (SME) for CAPA, non-conforming product, deviations (quality non-conformance) and compliance-related activities.
• Lead the end-to-end CAPA, non-conforming product and deviations (quality non-conformance) processes, including initiation, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
• Ensure CAPA activities are compliant with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Review and approve CAPA records to ensure completeness, accuracy, and timeliness. Coordinates CAPA Review Board, publish meeting minutes and ensures actions are completed on a timely manner.
• Monitor CAPA metrics and quality data sources trends to identify systemic issues and drive continuous improvement. Owns and/or supports the quality data trending process.
• Facilitate cross-functional CAPA review meetings and provide guidance on investigation techniques and problem-solving methodologies. Facilitates CAPA and lead-instructor / in-person QMS compliance training
• Implement and promote best practices in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Analyze quality data and trends to proactively identify risks and opportunities.

Compliance & Quality Systems

• Drive improvements in quality system processes, particularly CAPA effectiveness and timeliness.
• Maintain compliance with global regulatory requirements and internal quality management system (QMS) procedures.
• Support internal and external audits, including FDA inspections, notified body audits, and customer audits.
• Lead or support responses to audit findings, including CAPA development and implementation.
• Ensure inspection readiness and support regulatory submissions as needed.

Your qualifications

Required:

• Bachelor's degree in engineering, Life Sciences, or a related technical field required.

• Minimum of 5 years of experience in quality systems within the medical device or regulated industry.

• Strong experience managing CAPA systems and regulatory compliance activities.

• Strong data analysis and trending skills, with the ability to interpret complex quality data, identify patterns, and drive data-driven decision-making.

• Comprehensive knowledge of FDA QSR, ISO 13485, EU MDR, and related quality system regulations and standards.

• Strong understanding of root cause analysis tools and risk management principles.

• Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.

Preferred:

• Master's degree preferred.

• 7+ years of experience in quality systems, quality engineering, or regulatory compliance within a regulated industry (medical device, pharmaceutical, etc.).

• 2+ years of leadership or management experience in a quality systems role.

• Demonstrated success in leading quality system audits, managing CAPAs, and resolving complex quality issues.

• Exceptional leadership, interpersonal, and communication skills with the ability to influence at all levels of the organization.

• Proficient in eQMS platforms (e.g., TrackWise, MasterControl, ETQ) and Microsoft Office Suite.

• Lean Six Sigma certification (Green Belt or higher).

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.

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.

IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, 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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