Manager, Quality Assurance - Lenexa, KS

Requisition ID:6873

Job Title:Manager, Quality Assurance - Lenexa, KS

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 Manager, Quality Assurance is responsible for overseeing the Quality Management System (QMS) as per ISO 13485 / FDA QSMR medical-device Regulation. In addition, this position is responsible for ensuring that the product quality is compliant with the customer requirements. This role provides day-to-day leadership of the quality function, ensures compliance with applicable standards and regulations, and partners with Plant Manager for product or process enhancements. The position is critical in supporting the site's ongoing operational expansion-from single-shift to multi-shift production-while preserving product quality, process control, and QMS integrity.

Key Responsibilities:

Quality Management System Leadership

• Maintain, oversee, and continually improve the ISO 13485-compliant and FDA QSMR/QSR-compliant QMS.
• Develop, revise, and implement QMS procedures, work instructions, and controlled documents.
• Ensure QMS performance and control during operational expansion (e.g., going from one shift to two, increasing employees per shift), including process standardization, training, communication, and consistency of product quality across shifts.
• Incumbent reports to the Senior Director Quality Operations & Sustaining Engineering.

Product Quality & Process Oversight

• Ensure product quality for sterile disposable medical products, including in-process inspections, final inspections, packaging operations, sterilization and environmental controls.
• Monitor and analyze quality trends across all shifts; drive investigations and corrective actions for nonconformances, scrap, and process deviations.
• Partner with Operations and Engineering to support validation and re-validation activities (IQ/OQ/PQ) and continuous improvement projects.
• Lead and direct sterilization compliance and performance, including revalidation activities, routine cycle conformity, LAL/bioburden monitoring programs, and cross-functional coordination with operations, laboratories, and suppliers to ensure continued sterility assurance and regulatory compliance.
• Lead and direct cross-functional evaluation of process and design changes, ensuring appropriate risk assessments, regulatory impact reviews, and validation/verification activities are completed.
• Ensure change controls maintain compliance with FDA QSR/QSMR, ISO 13485, and product requirements without disrupting product quality, safety, or availability.
• Lead and direct employee training programs, ensuring timely onboarding, competency verification, and documented training compliance across all departments and shifts.

Post-Market Surveillance & CAPA Management

• Lead and direct complaint handling, MDR evaluation support, and post-market surveillance activities, including trend reporting and closure within defined timelines.
• Own the CAPA system, ensuring thorough root-cause analysis, appropriate corrective actions, trend monitoring, and verification of effectiveness.

Regulatory & Audit Support

• Represent the company during ISO audits, FDA inspections and customer audits.
• Support and/or lead regulatory submissions (e.g., 510(k), letters to file) as needed.
• Monitor and communicate changes to applicable regulations, standards, and guidance.

Supplier Quality Management

• Lead and direct supplier qualification, auditing, SCARs, performance monitoring, and quality agreements.
• Ensure incoming inspection effectiveness, risk-based supplier controls, and component traceability.

Metrics, Governance & Leadership

• Establish and track site quality metrics, objectives, and dashboards aligned to company goals.
• Prepare and present QMS performance and quality data during Management Reviews.
• Lead and develop Quality Technicians, Inspectors, and support roles across multiple shifts.
• Serve as the site Management Representative for QMS compliance.

Your qualifications

Required:

• Minimum 5-7 years in a regulated manufacturing industry (medical device, pharma, biotech, or similar).
• Bachelor's degree in engineering, Quality, Life Sciences, or related field.
• Hands-on experience maintaining product quality and QMS performance while expanding a manufacturing operation from one shift to two (or similar multi-shift expansion).
• Deep knowledge of FDA QSR/QSMR, ISO 13485, and medical-device quality principles.
• Proven experience managing audits (FDA, ISO, customers) and regulatory compliance activities.
• Strong background in complaint handling, CAPA, nonconformance management, and quality metrics.
• Experience supporting or managing validations (IQ/OQ/PQ).
• Demonstrated ability to lead and develop quality teams.
• Excellent written and verbal communication skills.

Preferred:

• Experience with disposable medical devices manufacturing or sterile packaging
• Supplier quality audit experience (lead auditor certification a plus).
• Experience with process improvement methodologies (Lean, Six Sigma, etc.).

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