Quality Assurance Specialist

Requisition ID: 5770
Job Title: Quality Assurance Specialist
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 Position Purpose / Summary
The major purpose of this position is to support the on-going activities required to support the assigned product family activities. These activities include but are not limited to:

• Leading Global Post Market Surveillance Activities
• Overseeing the Performance Driven Management and HPMS strategies
• Administrating the Quality Assurance and System Deliverables
• Managing Team Compliance Communications
• Administrating the Risk Management Files (Action Items)

Job Position Scope
The scope of the Quality Assurance Specialist position is to:

• Efficiently performing Complaint Handling (Investigations and/or Approvals), Failure Investigation (Quality Assurance, CAPA / QNC), and administratively executing High Performance Management System (HPMS)
• Communicate team accomplishments, project status, and challenges effectively throughout all levels of the organization

Job Position Accountabilities / Expectations
The Position Specific Accountabilities of the Quality Assurance Specialist position is to:

• Global Post Market (Complaint/ Failure Investigations)
  
  • Leading the following, but not limited to the following:
    
    • Complaint Handling investigations (including Contract Manufacturers)
    • Complaint Review Board/ Management Review
    • Manage and continuously improve the global complaint handling process.

• Global Post Market Reviews (GPMS Review, PSURs, etc...)
  
  • Leading the following, but not limited to the following:
    
    • Oversees the on-time execution of GPMS Reviews and PSURs
    • Post Market activity execution status communication and presentations.
    • Manage and continuously improve the global post market surveillance process.
    • Provide guidance and direction related to execution of Post Market Surveillance activities.
    • Understands and trains technical teams on the GPMS Process

• High Performance Management System (HPMS) and Performance Driven Management (PDM)
  
  • Overseeing the following, but not limited to the following:
    
    • Team Meeting Agenda, dashboards, Meeting Minutes, and Action Items
    • Stand-a-lone Risk Management File update and activities.
    • SharePoint Alignment and update
    • Actively lead proactive Audit preparedness activities
    • Actively participate in and/or facilitate the closure to corrective and preventive actions from observations

• Managing Team Compliance Communications
  
  • Administrating the following, but not limited to the following:
    
    • GEMBA team dashboards updates and status reviews
    • Team Action Item Mailbox execution
      
      • Communication to requestor and document the closure of action items
    • Support and Communicate Audit Status (Internal and External)
      
      • Review, Retrieve and Stage requested documents for audits

The General Expectation of the Quality Assurance Specialist position is to:

• Understand the Global Quality Objectives, Team Strategies to meet the goals
• Understand meeting etiquette by continually updating their business calendar for efficient time management
• Provide Recognition, Stories, and/or Feedback to associates
• Manage self in accordance with the expected approved Corporate Values,
• Participate actively with the project teams to facilitate the incorporation of all quality system elements
• Communicate with Business Partners to inform on HPMS and Quality Approaches
• Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position

Key Relationships / Customer Expectations
The Key Relationships / Customer Expectations of Quality Assurance Specialist position is to understand all levels of management within Technical Quality, Quality Systems, Research & Development
Key Leadership Values
The Key Leadership Values of the Quality Assurance Specialist position is to:

• Conduct self in accordance with the expected approved Corporate values.
• Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position

Qualifications
Required:

• B.S. in Quality Assurance or Quality Systems with a minimum of 1 years of collective experience in a medical device required
• Extensive experience in Complaint Investigation and assessing patient risk
• Experience writing conclusions of root cause analysis, summaries of complaint investigations, and communicating results
• Proficient with Microsoft Office programs
• Presentation Creation
• Travel up to 0-5% per month

Preferred

• Experience in Quality Systems (ISO 13485), Auditing, Complaint Handling, Corrective, and Preventative Actions (CAPA)
• Excel user comfortable creating pivot tables

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