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 109,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

ABOUT ABBOTT DIAGNOSTICS:

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 109,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbotts life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Were 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 Abbotts diagnostics instruments, providing lab results for millions of people.

Our location in Irving, Texas currently has an opportunity for a Project Manager Risk Management. You will be the Subject Matter Expert providing product safety Risk Management guidance and direction to all areas associated with the design and manufacture of molecular diagnostic products.

WHAT YOULL DO

* Develop, implement, and maintain a risk management process in the Quality System that conforms with ISO 14971 across product realization by providing strategic and tactical direction.

* Maintain a sound, consistent, and sustainable approach to risk management.

* Manage health and safety risk by identifying and communicating product safety risks at each phase of the product lifecycle.

* Create and maintain risk management records compliant with international standard ISO 14971 and Divisional procedures.

* Define best practices to aid in the implementation of risk management requirements.

* Provide guidance to product teams regarding risk identification, assessment, control, and communication.

* This position will work under Product Development direction and will report to the Manager, Risk Management.

* Effective risk management improves product safety, consistency, and reliability.

* Risk management is a required tool to demonstrate compliance with regulations such as CFR and IVDD.

EDUCATION AND EXPERIENCE YOULL BRING

Required

* Bachelors degree required.

* Minimum of 3 years experience in product safety risk management in research/engineering, new product development, operations, and/or complaint handling.

* Experience with risk management (ISO 14971) required.

Preferred

* Life science or engineering degree preferred to understand and interpret technical issues Master's preferred

* Experience should include work with regulations and standards affecting In Vitro Diagnostic product design, development and manufacture.

* Knowledge of diagnostics instruments, reagent products, development, manufacture, and customer use is desirable.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

* Training and career development, with onboarding programs for new employees and tuition assistance

* Financial security through competitive compensation, incentives and retirement plans

* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

* Paid time off

* 401(k) retirement savings with a generous company match

* The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

JOB FAMILY:

Project Management

DIVISION:

ATM Transfusion

LOCATION:

United States > Irving : LC-02

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf