Demo

Senior Specialist Quality Assurance

1003 Abbott Laboratories
Amenia, NY Full Time
POSTED ON 3/5/2025
AVAILABLE BEFORE 5/5/2025
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.

     

JOB DESCRIPTION:

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.
  • 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.
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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 Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.   

This Senior Specialist, Quality Assurance will oversee conducting quality-related activities to deliver consistent, high quality documents, services, products and processes.

What you’ll work on

  • Defines project goals and milestones. Responsible for timely project completion.
  • Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope.
  • Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on crossfunctional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders.
  • Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.
  • Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines.
  • Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
  • Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
  • Risk Management - Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk. Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality.
  • Complaint Evaluation - Investigates complex complaints with little management oversight. Provides solutions to a wide range of problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Ensures compliant documentation in area of responsibility.
  • Design Control / Documentation & Change Control - Formulates thorough reason and justification for change. Identifies critical parameters associated with change.
  • Represents the site as an SME or Process Community member.
  • Quality Engineering - Applies solid understanding of quality system elements from product inception through launch. While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.
  • Validation - Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem.

Required Qualifications

  • Bachelor's Degree with minimum 5 years In Quality or related field experience; Less experience may be appropriate with advanced degree.
  • Has a history of completing successful projects and driving positive compliance outcomes.

Preferred Qualifications

  • Preferred experience in the Healthcare industry.

What We Offer

At Abbott, you can have a good job that can grow into a great career. We offer: 

  • 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 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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

$75,300.00 – $150,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Texas > Austin : 12501B Research Boulevard

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Salary : $75,300 - $150,700

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