Avanos Medical Hiring for Senior Quality Engineer, Global Post Market Surveillance (GPMS) at Alpharetta, GA  Full Time

Requisition ID:5070

Job Title:Senior Quality Engineer, Global Post Market Surveillance (GPMS)

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.

The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer.

If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee’s job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for reasonable accommodation will have their job offer revoked.

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 Role

Senior Quality Engineer- Global Post Market Surveillance (GPMS)

The major purpose of this position is to lead the necessary ongoing activities required to support assigned product categories. These activities as they relate to Post Market Surveillance and EU MDR requirements include but are not limited to identifying strategic focus areas for continuous improvements, product/process enhancements, implementing proactive quality activities, monitoring and measuring the overall performance, and ensuring compliance to quality systems and regulatory requirements.

This position provides global support for Global Post-Market Surveillance and processes and activities; he/she provides technical leadership within Avanos Medical; coaches and mentors other technical team members to increase technical understanding and effective communication of technical/systems accomplishments. He/she provides protection to technologies and products through the appropriate use of patents and trade secrets.

General Expectations and Accountabilities:

1. Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position.
2. Manage self and/or team in accordance with the expected behaviors of the Leadership Qualities.
3. Provides technical leadership in solving more challenging technical problems related to quality issues and technologies.
4. Develops, initiates, and implements new quality concepts, tools, and strategies to improve business practices.
5. Solves highly technical complex problems, provides expertise in related specific field of knowledge, and consults on complex issues and projects.
6. Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert.

Position-Specific Accountabilities:

1. Work within cross-functional teams to identify and lead continuous improvement projects. Including where appropriate, implementing the Design of Experiments and Problem Analysis/Solving concepts within the organization
2. Provide engineering assistance for complaint investigations to drive successful investigations with good root cause. Including implementing the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions; and initiation of action events as a result of complaint investigations and follow-up on the effectiveness of those actions.
3. Proactively interact with members of sustaining engineering and R&D to drive resolution of failure analysis for product malfunctions. Including initiation of Risk Analysis and Medical Evaluations resulting from the complaint investigation and reviews, escalating as appropriate.
4. Assist in performing internal audits and providing GPMS-related support for all corporate and notified body audits.
5. Drive compliance with EU MDR requirements as it relates to GPMS Report/PMS Plans.
6. Drive active post-market surveillance activities including the design, development, and execution of such studies.
7. Work with the team to ensure that all required data to support EU MDR efforts is pulled for assigned GPMS reports and submitted for cross-functional review to assigned team members.
8. Prepare documentation and reports for Senior Management, Quality Assurance, and Regulatory Affairs and support each product platform with relevant post-market/supplier quality data. Present GPMS-related data to all levels of the organization.
9. Work hand in hand with Clinical Affairs to align all EU MDR data including PMS plans, PMS reports, PSURs, CERs, etc.

Your Qualifications

Required Qualifications:

Education: A B.S. in Engineering, Science, or related discipline.

• Minimum of seven (7) years of collective experience in Quality Assurance, R&D, or related field in a medical device environment.
• Must be detail-oriented, and have excellent customer service, leadership, and communication skills with co-workers and customers.
• Must have exceptional technical writing and data analysis skills.
• Must be team-oriented with an ability to coach others. Must have excellent problem-solving skills, and oral and written communication skills.

Preferred Qualifications:

• CQE certification or Six Sigma Certification are desirable.
• Experience with Microsoft Office Package.
• FDA QSR, MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, ISO 13485, MDSAP, CMDR, Statistical Analysis Tools, Minitab, SAP, Document Control software such as EtQ or Agile, Six Sigma, Lean Manufacturing.

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 .

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.

Free onsite gym | benefits on day 1 | HQ region voted ‘best place to live’ by USA Today