Associate Product QA Specialist

Company: Abbott
Location: Temecula
Posted on: April 26, 2024

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You'll also have access to:

• 
  
• 
  Career development with an international company where you can grow the career you dream of .
  
  
• 
  Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  
  
• 
  An excellent retirement savings plan with high employer contribution
  
  
• 
  Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor's degree.
  
  
• 
  A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  
  
• 
  A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  
  
  The Opportunity
  This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ---ngersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
  Our location in Temecula, CA currently has an opportunity for a Associate Product QA Specialist
  THIS IS AN ONSITE DAILY POSITION.
  MAIN PURPOSE OF ROLE
  Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
  MAIN RESPONSIBILITIES
  
  • 
    
  • 
    Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
    
    
  • 
    Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
    
    
  • 
    Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
    
    
  • 
    Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
    
    
  • 
    Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
    
    
  • 
    Apply codes to events to facilitate product performance records.
    
    
  • 
    Review coding and investigations with engineering, laboratory, and other internal staff.
    
    
  • 
    Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
    
    
  • 
    Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
    
    
  • 
    Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
    
    
  • 
    Individual influence is typically exerted at the peer level.
    
    
  • 
    Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
    
    
  • 
    May exercise authority within pre-established limits and approval.
    
    
  • 
    Failure to achieve results can normally be overcome without serious effect on the business.
    
    
    QUALIFICATIONS
    Education
    Bachelors Degree Required
    Experience/Background
    
    • 
      
    • 
      0-2 years of related work experience with a basic understanding of specified functional area.
      
      
    • 
      General knowledge and basic application of business concepts, procedures and practices.
      
      
    • 
      Will perform this job in a quality system environment.
      
      
    • 
      Failure to adequately perform tasks can result in noncompliance with governmental regulations.
      
      
    • 
      Learns to use professional concepts and company policies and procedures to solve routine problems.
      
      
    • 
      Works on problems of limited scope.
      
      
    • 
      Minimal independent decision making.
      
      
      WHAT WE OFFER :
      At Abbott, you can have a good job that can grow into a great career. We offer:
      
      • 
        
      • 
        A fast-paced work environment where your safety is our priority
        
        
      • 
        Training and career development, with onboarding programs for new employees and tuition assistance
        
        
      • 
        Financial security through competitive compensation, incentives and retirement plans
        
        
      • 
        Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
        
        
      • 
        Paid time off
        
        
      • 
        401(k) retirement savings with a generous company match
        
        
      • 
        The stability of a company with a record of strong financial performance and history of being actively involved in local communities
        
        
        Apply Now (https://www.jobs.abbott/us/en)
        
        • 
          
        • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
          
          Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
          Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
          Abbott is an Equal Opportunity Employer, committed to employee diversity.
          Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
          The base pay for this position is $48,000.00 - $96,000.00. In specific locations, the pay range may vary from the range posted.
          An Equal Opportunity Employer
          Abbot welcomes and encourages diversity in our workforce.
          We provide reasonable accommodation to qualified individuals with disabilities.
          To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Keywords: Abbott, Yorba Linda , Associate Product QA Specialist, Other , Temecula, California