Quality Professional - Risk Management

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.

     

JOB DESCRIPTION:

The Opportunity

This Quality Professional position is focused on supporting the implementation & maintenance of the risk management quality subsystem and associated processes in ARDx ID, in accordance with applicable regulations and standards incl. ISO 146971. Additionally, the Quality Professional for Risk Management leads activities assigned to them, collating needed inputs and working collaboratively with a broad cross-functional team.

What You'll Work On:

·  Supports the implementation and maintenance of the effectiveness of the Quality System with respect to risk management.
·  Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures and templates compliant with applicable risk management standards and regulations such as ISO 14971.
·  Uses critical thinking to provide solutions that are compliant, innovative and consistent with organizational objectives.
·  Coordinates and leads activities associated with the usage of risk management, sharing expertise in support of build of risk management files and risk management tool utilization.
·  Partners with key functions (e.g. R&D, QA, Medical Affairs, Regulatory Affairs, Clinical Affairs, product, instrument and software teams, Field Assurance, and manufacturing facilities) to utilize risk management tools e.g. FMEAs, Risk Analysis, On-market risk assessment etc.
·  Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.
·  As a risk management subject matter expert, supports audits and additional information request inquiries relating to Risk Management.
·  Represents ARDx ID at risk management communities of practice.
·  Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
·  Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.

Required Qualifications:

·  Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
·  At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.

Preferred Qualifications:

·  Preferred experience in the Healthcare industry.
·  Has a history of completing successful projects and driving positive compliance outcomes.
·  Previous Design Transfer experienc

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
·  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
·  Vacation – 3 weeks of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
·  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 base pay for this position is
$65,900.00 – $131,900.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

United States > San Diego : 4545 Towne Center Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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