Specialist Quality Assurance

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:

Specialist Quality Assurance

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What You'll Work On

• Initiates and manages the complaint file. Maintains accurate entry of complaints in the system.

• Act as the primary complaint team conduit to the Irving, Texas site, interacting with supporting functional areas

• Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints.   Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. 

• Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints.

• Prepares customer letters with investigation findings.  Is diligent of any unusual trends in product complaints and communicates them to management.

• Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings). Archives complaint records and retrieves information on closed investigations.

• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.  Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.  Performs other related duties and responsibilities, on occasion, as assigned.

• Quality System Compliance -Maintains awareness of standards that regulate our industry.

• Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.

• Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

• Risk Management - Applies basic Risk Management principles to work.

• Audit support. Provides audit support commensurate with process knowledge.

• Executes complaint data pulls supporting internal customers

Required Qualifications

• A Bachelor’s degree preferably in the healthcare, science, or technical fields or an equivalent combination of education and work experience. An Associate’s Degree would also be acceptable with the addition of 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work or and equivalent combination of education and work experience.

Preferred Qualifications

• Good, general understanding of the standards and regulatory bodies that regulate our industry

• Strong communication skills

• Demonstrates technical and business competencies that drive results and continuous improvement.

• Ability to work independently

• Experience in the Healthcare industry

• Complaint Handling / Tracking and Trending

• Customer Communications

• Audit Support

• Data Mining

• Instrument Hardware/Software

• CHaRM

• Trackwise

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

     

The base pay for this position is

$60,000.00 – $120,000.00

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

     

JOB FAMILY:Operations Quality

     

DIVISION:TM Transfusion Medicine

        

LOCATION:United States > Irving : LC-02

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 5 % 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), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Work in noisy environment, Work requiring repeated bending, stooping, squatting or kneeling

     

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