Principal Quality Engineer
Company: Avanos Medical
Posted on: September 19, 2023
Job Title:--Principal Quality Engineer
Job Country:--United States (US)
Here at Avanos Medical, we passionately believe in three
- Making a difference in our products, services and offers, never
ceasing to fight for groundbreaking solutions in everything we
- 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 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
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
Create and ensure the effectiveness of the Manufacturing Control
- Quality Engineering Leadership for Medical Device New Product
- 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
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
- B.S. in Engineering (prefer
- 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
- Experience defending Risk Management Documentation in an
- Statistical software experience, such as Minitab, JMP,
- 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
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
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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