QA Specialist III

Abbott; Westfield (IN); On-site; USD 22,000 - 44,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Education benefits

Job summary

Abbott in Westfield, IN is hiring a QA Specialist III to ensure manufactured and sterilized units meet internal procedures before release. The role emphasizes documentation control, SDLC compliance, and collaboration with manufacturing teams in a 3:00pm-11:30pm schedule with potential Saturday overtime.

You will review lot history records, manage non-conforming materials, perform SAP transactions, and support Design History File approvals in a regulated healthcare environment.

Qualifications

• High School Diploma or GED required.
• Minimum 4 years related work experience.
• Solid knowledge of business concepts, procedures and practices.
• Quality system environment experience.
• Ability to perform complex assignments with judgment and initiative.

Responsibilities

• Review manufacturing documentation by obtaining lot history records and non-conforming material reports and ensure conformance.
• Track documentation discrepancies and maintain a mechanism to identify trends.
• Notify manufacturing personnel of documentation issues and inform formally on discrepancies.
• Confine discrepant materials in a quarantine area until resolution.
• Release product in SAP after Product Release Authorization and LHR review.
• Review and approve Design History Files and related EOs for archive release.
• Advise manufacturing personnel and project leaders as the documentation expert.
• Coordinate clinical product release paperwork to approved sites.
• Audit materials and the work of others through inspection, testing, and documentation.

Skills

Quality assurance

Documentation

Auditing

Problem solving

Regulatory awareness

Education

High School Diploma / GED

Tools

SAP

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 122,000 colleagues serve people in more than 160 countries.

QA Specialist III

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 Westfield Indiana location in the Structural Heart Division. Hours are 3 :00pm to 11 :30pm Mon - Fri, with occasional Saturday overtime.

MAIN PURPOSE OF THE 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.

Main Responsibilities

• 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.

Required Qualifications

• High School Diploma / GED
• Minimum 4 years Related work experience.
• Applies solid knowledge of business concepts, procedures and practices, and a complete understanding fundamentals in a functional area, and working knowledge of other related disciplines.
• Will perform this job in a quality system environment.
• Performs complex assignments usually without established procedures.
• Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.

Preferred Qualifications

Associates Degree or some college credits performed

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 X @AbbottNews.

The base pay for this position is $15.80 – $31.60 per hour. In specific locations, the pay range may vary from the range posted.