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Quality Engineer

4 months ago

Alpharetta, United States Avanos Medical Full time
Requisition ID: 5753

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.

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 a 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 www.avanos.com.

Job Description:

The major purpose of this position is to lead the on-going quality activities required to support commercialized medical devices for the company. This role provides quality engineering leadership by: Collaborating with R&D and manufacturing on product opportunities post-commercialization, monitoring and analyzing complaint data, leading root cause corrective actions and proactively supporting business strategies. These activities include but are not limited to: Support design changes, product enhancements, material changes, and process changes; investigation of product non-conformances; communication with customers, ensure compliance to quality system requirements; support the company's manufacturing facilities and supply base.

Job Position Accountabilities / Expectations:
  • Actively participates in and/or facilitate the development of deliverables required to qualify product design changes ensuring that customer requirements and specifications are met
  • Maintains the Risk Management files which includes Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for assigned product families
  • Solves challenging technical problems, provides expertise in related specific field of knowledge and consults on complex issues and projects
  • Works within cross-functional teams to lead investigation of customer product complaints as needed
  • Utilizes Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks
  • Leads Global Post Market Surveillance analysis, trending, and reporting
  • Ensures timely closure of assigned active complaints (typically 3rd party supplied products) providing tracking and trending data, as needed
  • Partners with Supplier Quality to facilitate the completion of Supplier Corrective Actions and to build quality relationships
  • Develops, initiates, and implements new quality concepts, tools and strategies to improve business best practices
  • Provides technical leadership in solving more challenging technical problems related to quality issues and technologies
  • Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert by Product Supply, Research and Development, and Manufacturing Business Partners
  • Conducts self in accordance with the expected company behaviors
  • Ensures that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position
Qualifications / Education / Experience / Skills Required
  • B.S. in Engineering, Science, or equivalent
  • Minimum of 5 years of collective experience in product development, manufacturing and/or quality within a medical device environment
  • Proficient with Microsoft Office Programs
  • Strong understanding of statistical concepts, test method validation, process qualification, ISO 13485 and ISO 14971 preferred

Actively led in the development of deliverables required to qualify product design changes ensuring that customer requirements and specifications are met.

Maintained the Quality Management System and Risk Management files which includes Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for assigned product families.

Solved challenging quality technical problems, provided expertise in related specific field of knowledge while working with cross-functional teams to lead investigation of customer product complaints as needed.

Led Global Post Market Surveillance analysis, trending, and reporting, and utilized Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks.

Partnered with Supplier Quality to facilitate the completion of Supplier Corrective Actions and to build quality relationships and implemented new quality concepts, tools and strategies to improve business best practices.

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.

free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today