Quality Associate III - Lenexa, KS

Job Title:

Quality Associate III - 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

The QA Technician shall perform and record receiving and in-process testing including both visual, dimensional, and functional. Will also perform testing as part of validations, deviations, or other special projects. Will create, update and review inspection and test protocols. Will have in depth knowledge of the Quality Management System. Will create, update and review QMS documents based on processes changes to assure compliance.

Will review documentation for completeness and compliance. Will analyze data using Excel. This position will work the hours of production, usually 6:00AM-4:30PM Monday through Thursday. Depending on needs, hours start time can vary between 6 and 7AM. Additionally, 3-12 hours shifts either Monday through Wednesday or Thursday through Saturday may be implemented in the future.

General Expectations and Accountabilities:

• Perform receiving and in-process testing for products and packaging
• Record receiving and in-process testing into the appropriate quality forms or Excel spreadsheets and analyze results
• Perform verification of area clearances, including labeling verification where applicable.
• Verify pick lists are properly documented
• Perform special testing required in root cause analysis, deviations, validations, etc.
• Identify, report, and contain non-conforming product
• Track non-conforming product trends and progress and report results
• Conduct internal audits, review and analyze data and report results
• Review DHR packets for completeness and compliance to FDA and ISO requirements at end of work order
• Create, update and review QMS documents and protocols
• Manage document control responsibilities per FDA and ISO requirements
• Identify and communicate potential Quality issues to Engineering, Manufacturing, and Operations

Required

Strong attention to detail to follow procedures and accurately record results

Ability to analyze and interpret data / collect data / problem solver

Ability to work independently and take the lead in high pressure situations

Excellent organizational and multi-tasking skills

Understanding of Quality Management Systems

Experience solving problems technical, quality and compliance in nature

High level of proficiency with Microsoft Outlook, Word, and Excel a must

Minimum of 2-3 years of experience working in a quality role in a highly regulated industry (medical device, pharma, aerospace) preferably in cGMP or GLP environment

Experience with quality instruments such as force gages, calipers, pressure meters, vision equipment, pin gages, etc

Preferred

• Experience with ANSI/ASQ sampling plans is preferred
• Experience with ISO 9001 or 13485 preferred

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…