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JOB DESCRIPTION:

Engineering Change 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 Woodridge, St. Paul, MN location for our Structural Heart business.  

Structural Heart Business Mission: Why We Exist: Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As an Engineering Change Specialist, you will play a critical role in supporting the Structural Heart teams by managing the documentation control changes and maintaining high-quality, compliant documentation that supports process development, validation, and manufacturing excellence.

What You’ll Work On

This position is responsible for processing, organizing, and maintaining Engineering Documents in a controlled system. Organize and maintain the Documents in a controlled system to meet current regulatory requirements and Abbott policies and procedures related to Document Control and control/distribution of current procedures. Support the document owners/Subject Matter Experts (SME) to comply with company policies. Provide effective communication both with oral and written format to parties involved in document update.

What You’ll Do

• Assist Subject Matter Experts (SME) with document updates in implementing and maintaining an accurate, cGMP compliant documentation change control.
• Coordination of updating the AES Program documents to include current references to applicable Abbott policies.
• Write and review department documents.
• Coordinate and maintain document-controlled systems.
• Initiate Change Request for documents or data changes.
• Review, edit and process changes to controlled documentation such as procedures, form, etc., in an electronic document management system.
• Proofread own work and backup as a proofreader as needed.
• Route documents for approval.
• Ensure proper approvals have been obtained prior to final release of document and coordinate effective dates with Subject Matter Experts (SME). Maintain tracking and distribution of documentation.
• Maintain master and historical document files and assist audits as required.
• Provide updates for Corporate Glossary.
• Represent department at inter-departmental meetings as required.
• Coordinate the periodic review with SME.
• Review and update departmental procedures as needed.
• Perform other activities as needed by the business.

Required Qualifications

Education

• High School Diploma / GED

Experience/Background

• Some working knowledge of cGMP regulations and industry documentation standards.
• Strong ability to communicate verbally and in writing with all levels.
• Strong Microsoft Office knowledge base (Word, Excel, PowerPoint, Outlook).
• Exceptional organizational skills and attention to detail.
• Ability to manage multiple tasks and prioritize accordingly in a fast-paced environment.
• Willingness to learn and perform other activities as required by the business
• Preferred but not required: Experience working with electronic document management systems (EDMS) and enterprise resource planning (ERP) platforms such as Agile, MasterControl, Windchill, or SAP.
• Preferred but not required- 3+ years of experience in documentation control or technical writing in a regulated industry (medical device, pharmaceutical, or biotech preferred).

Apply Now

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

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

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