Quality Assurance Specialist

Company : Abbott Laboratories

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.

Quality Assurance Specialist

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.

The Opportunity
This position works out of our Dallas, TX location in the Transfusion Medicine, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. 

The primary function of the Quality Assurance Specialist is to help manage the audit process. Acts as a team member to complete assigned site audit / compliance projects including all interrelated activities. Identifies and elevates critical issues. Participates in compliance initiatives and audit process improvements. Support the compliance group in developing and maintaining standard audit processes to ensure compliance with local, divisional and corporate procedures, as well as conforming to the Quality Systems Regulations (21CFR 820), ISO 13485:2003 and other applicable regulations and standards

What You’ll Work On

• Plans, prepares and executes internal and external audits.

• Supports record archival activities, including coordinating record retrieval from archives.

• Prepares updates and maintains documentation for internal and external audits

• Assists management in development of an effective system for integrating information from internal audits.

• Provides reports in a timely manner.

• Includes the review of recent audit activity, analysis of data, preparation and follow up on action items.

• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.

• The individual in this position is responsible for audit preparation, execution and reporting.

• This position is accountable for the preparation and reporting of Quality related documentation.  Failure to do so would negatively impact the business by inaccurately reporting information required for Management Quality decisions.

• Self-starter who can work independently or as part of a cross functional team.

• Adaptable and flexible to changing job demands.

• Note: This job description describes the principal and main elements of the job.  It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.

Required Qualifications

• Bachelors degree in scientific, technical, or compliance discipline.

• 2 -3 years experience in the industry

Preferred Qualifications

• 2-3 years experience in a quality assurance function

• Prior experience with quality compliance audits

• Prior experience collaborating cross functionally

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: (url removed)

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 (url removed), on LinkedIn at (url removed), and on Facebook at (url removed).

The base pay for this position is $60,000.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.

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