Quality Specialist IV

4 weeks ago

Westfield, United States Abbott Laboratories Full time
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.

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

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 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 Westfield, IN, location in the Structural Heart Division.

Main Purpose of Role

The Quality Assurance Specialist position exists to ensure that all units, either commercial or clinical product, have been manufactured and sterilized in accordance with internal procedures prior to release.

What You’ll Work On

  • Reviews Manufacturing documentation by obtaining all lot history records and non-conforming material reports and ensuring that they are compiled in accordance with internal procedures.
  • Tracks Documentation discrepancies by maintaining a mechanism by which discrepancies with manufacturing documentation can be tracked to determine trends, etc.
  • Notifies Manufacturing personnel of documentation issues by providing feedback immediately upon discovery of issues, and, on a periodic basis, informing manufacturing personnel in a more formal manner of discrepancies with manufacturing documentation.
  • Confines discrepant materials by maintaining a Quarantine area whereby discrepant materials are physically located until they are resolved and can be released.
  • Releases product by performing the necessary transactions in SAP in the sterile cycle to release product upon receipt of the Product Release Authorization and completion of LHR review.
  • Reviews and approves Design History Files by obtaining and verifying the contents of DHFs and approving the Engineering Order authorizing release into the Archive department.
  • Advises Manufacturing personnel and project leaders by functioning as the "expert" in the area of documentation compliance.
  • Coordinates Clinical product by completing appropriate paperwork to release clinical product to approved sites.
  • Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components sub-assemblies and documentation.

Shift

This position is on 1st shift. Monday through Friday, 6:00 am - 2:30 pm.

The rate of pay for this position is $25.00/hour.

Required Qualifications

  • H.S. diploma or equivalent plus 5+ years of related work experience or equivalent combination.
  • Two-year degree or some college credits preferred.
  • Applies solid knowledge of business concepts, procedures and practices, and a complete understanding fundamental in a functional area, and working knowledge of other related disciplines.
  • Will perform this job in a quality system environment.

Apply Now

* 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

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 $16.55 – $33.15 per hour. In specific locations, the pay range may vary from the range posted.

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