Quality Engineer - Sr Prof

Requisition ID:6532

Job Title:Quality Engineer - Sr Prof

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.

The role

The purpose of this position is to lead the Risk Management activities and provide guidance for implementing Design Control during the New Product Development process for innovative medical devices.

General Expectations and Accountabilities:

• Independently develop Risk Management files; including Preliminary Hazards Analysis, Risk Analysis Document, Design FMEA, Use FMEA & Software FMEA for new products.
• Support the development of the Process FMEA and Manufacturing Control Plan documentation with our manufacturing partners.
• Provide technical leadership to resolve challenging technical problems related to quality issues and guide the team through root cause analysis investigations.
• Ensure completion of design history file documentation per Avanos procedures.

Position Specific Accountabilities:

• 
  
  
  
  • Quality Leadership for the cross-functional team during Medical Device New Product Development (90% of time)
  • Facilitate and actively participate in the development of deliverables required for medical device product development ensuring adherence to the Avanos design control process.
  • Lead and ensure compliance to all risk management requirements.
  • Actively participate in the development of statistical plans and rationale for design control activities/requirements.
  • Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire product design process.
  • Develop Device Master Records and ensure design transfer completion and manufacturing readiness per Avanos design control process.
  
  
  
  

Systems Compliance and Audit Support (10% of time):

* Implement the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions.

* Support notified body and internal audits.

Your qualifications

Required:

• B.S. in Engineering (prefer Biomedical/Mechanical/Electrical)
• 5-7 years of experience in product development & design control
• Medical Device quality experience required, Medical Electrical preferred
• Statistical software experience, such as Minitab, JMP
• Microsoft Office suite
• The ability to lead and influence others
• The ability to travel to support project needs (international may be necessary)
• Ability to collaborate on-site in Alpharetta HQ (3 days/week)

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