Specialist, Quality Systems (Training & Documentation)

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.

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 can work out of our Livermore, CA or Orlando, FL location in the Abbott Heart Failure, Acelis Connected Health business.  Our Heart Failure solutions are helping address some of the World’s greatest healthcare challenges.

As the Senior Document Control and Training Specialist, you are responsible for ensuring processes associated with Quality Training System are in compliance to internal and external regulations, procedures and standards.

What You’ll Work On

• Manage the site Documentation System and the QA Work Order systems.

• Assure that all QA documents meet established divisional, corporate and regulatory standards and that these documents are an efficient, effective system for both their use and Quality Assurance.

• Identify gaps in Documentation and Systems and take necessary actions to correct. 

• Ensure change requests identify all documents affected and all appropriate parties are reviewing the document prior to implementation to assure change control is achieved.

• Updates global and local standard operating procedures and work instructions.

• Interface with SMEs; business functional areas and site QA as necessary to design and develop QA training courses/materials to meet business needs.

• Responsible for maintaining and reporting on the compliance of the quality training processes.

• Analysis and generates data and KPI metrics related to Quality Training for inclusion in Management Reviews.

• Maintain the data integrity of SUMTotal LMS to ensure training data is audit ready at all times.

• Work closely with Division QA and site QA leadership to continuously improve QA training.

• Provide guidance and direction to QA training resources at the site.  Balances the team’s workload and is responsible for performance management.

• Help to conduct QA training needs assessments and gap analysis. 

• Help establish training effectiveness measures and evaluate QA training effectiveness.  Analyze data to drive continuous improvement of QA training content.

• Responsible for the ongoing evaluation and implementation of continuous improvement in relation to QA training/learning materials/courses.

Required Qualifications

• Bachelor’s Degree (± 13 years) or relevant education and experience

Preferred Qualifications

• 2 or more years of medical device related experience

• Strong Experience with Doc Control and Training Systems

• Knowledge of Regulated Industries

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 Twitter @AbbottNews.

The base pay for this position is $66,700.00 – $133,300.00. In specific locations, the pay range may vary from the range posted.