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Principal Quality Engineer

Company: Avanos Medical
Location: Alpharetta
Posted on: September 19, 2023

Job Description:

Requisition ID:--4954

Job Title:--Principal Quality 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.--

    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 .

    The role

    The purpose of this position is to lead the Risk Management and Design Control activities related to the New Product Development and necessary on-going activities required to support existing products.

    General Expectations and Accountabilities:

      • Development of the Risk Management File (RMF) and ensure compliance with all risk management principles.

      • Development of Design History File (DHF) and building Device Master Records (DMR)-- --documentation to ensure a smooth transfer to the production environment.
      • Provides technical leadership in solving challenging technical problems related to quality issues and technologies and consults on complex issues and projects.
      • Subject Matter Expert for Software Risk Analysis

        Position-Specific Accountabilities (90% of the time):

        • Development of the Risk Management Files; including execution of the Product Hazards Analysis, Design FMEA, Use FMEA, and Process FMEAs for new products.
        • Create Software FMEAs and mentor team on completion of required Software deliverables during Design History File development

        • Create and ensure the effectiveness of the Manufacturing Control Plans.
          • Quality Engineering Leadership for Medical Device New Product Development
          • Facilitate and actively participate in the development of deliverables required for medical device product development ensuring adherence to the Avanos design control process. Provides guidance and suggestions for best practices.
          • Actively participate in the development of statistical plans for sample sizes and inspection characteristics.
          • Guide the development team on strong rationales for design control activities and device 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 development lifecycle. --Lead investigations as needed.

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

              • Implement the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions.
              • Support notified body and internal audits.
              • Partner with Quality Systems team to continuously improve the design control process for software and electrical medical devices.

                Your qualifications


                • B.S. in Engineering (prefer Biomedical/Mechanical/Electrical)
                • A minimum of 10 years of collective experience in product development and quality in a medical device environment.
                • A minimum of 3 years executing the development of Software FMEA and/or Software FTA's
                • A minimum of 5 years developing and improving, efficient and effective product development processes, for Electromechanical Devices.
                • Experience defending Risk Management Documentation in an audit
                • Statistical software experience, such as Minitab, JMP, Excel
                • The ability to lead and influence others
                • The ability to travel up to 10% at times

                  • Working knowledge of IEC 60601-1
                  • Working knowledge of IEC 62304
                    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

Keywords: Avanos Medical, Alpharetta , Principal Quality Engineer, Engineering , Alpharetta, Georgia

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