Senior Design Quality Assurance Engineer

Avanos Medical; Atlanta (GA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Benefits on day 1

Onsite gym

HQ region recognized

Job summary

Avanos Medical in Alpharetta, GA, seeks a Senior Design Quality Assurance Engineer to lead Risk Management and Design Control for new product development and post-market design changes. The role emphasizes regulatory compliance, cross-functional leadership, and robust quality systems throughout the development lifecycle.

You will guide risk analyses, validation activities, and continuous improvement initiatives while partnering with project teams to ensure regulatory readiness and effective

Qualifications

• B.S. in Engineering, Science or Statistics is required.
• Minimum 7 years of experience in product development and quality in a medical device environment.
• Minimum 3 years developing and improving product development processes.
• Position will be based in Alpharetta, GA and work in the office Tuesday–Thursday.

Responsibilities

• Develop/Maintain the Risk Management File (RMF) ensuring ISO 14971:2019 alignment.
• Lead Design and Development Files for regulatory submissions and production transfer.
• Provide technical and quality leadership to solve complex quality issues and advise on projects.
• Lead investigations and drive corrective actions across the lifecycle.
• Support supplier qualification and component qualifications with proper documentation.

Skills

Risk Management

Design Control

ISO 14971 Compliance

FMEA

Root Cause Analysis

Regulatory Submissions

Quality Leadership

Education

B.S in Engineering, Science or Statistics

Job description

Requisition ID: 7383

Job Title: Senior Design Quality Assurance 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. For more information, visit www.avanos.com .

The Role

The purpose of this position is to lead the Risk Management and Design Control activities in support of both New Product Development and Post-Market Design Changes.

General Expectations And Accountabilities

• Development of the Risk Management File (RMF) ensuring compliance to all risk management principals beginning in new product development and the continued maintenance in the post-market phase.
• Guide development of Design and Development Files to ensure documentation adequacy for regulatory submissions and for a smooth transfer to the production environment.
• Provides technical and quality leadership in solving challenging technical problems related to quality issues and technologies and consults on issues and projects.

Responsibilities

• Development/Maintenance of the Risk Management files; includes ownership of the Product Hazards Analysis, Design FMEA and Use FMEA, Software FMEA (as applicable) and provides support to the manufacturing teams for the Process FMEAs. Authors and ensures cross-functional alinment with the Risk Management Reports and Periodic Risk Reviewes ensuring adherence to ISO 14971:2019 and Avanos Policies and Procedures.
• Provides Design Quality Leadership for Medical Device Design and Development Activities for designs including both New Product Devopment and Post-Market Design Changes. Ensures adherence to ISO 13485:2016 and Avanos Policies and Procedures.
• Actively participate in the development of statistical plans and rationale for design control activities/requirements. Supports sample sizes with risk based rationales.
• 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 development lifecycle. Lead investigations as needed.
• Support the qualification of new suppliers, or new components with existing suppliers, to ensure appropriate qualifications are executed and to provide guidance for technical activities in compliance with supplier monitoring.

Systems Compliance And Audit Support

• Implement the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions.
• Support notified body and internal audits.
• Support quality system processes requiring design quality input and data analysis

Qualifications

Required:

• A B.S in Engineering, Science or Statistics.
• A minimum of 7 years of collective experience in product development and quality in a medical device environment.
• A minimum of 3 years developing and improving, efficient and effective product development processes
• Position will be based in Alpharetta and and expected to work in the office Tuesday – Thursday.

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.

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