Quality Systems Analyst

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:

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
• 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.

 

Our location in Temecula, CA currently has an opportunity for a Quality Systems Analyst.

THIS IS AN ON-SITE DAILY ROLE.

The Opportunity

This position works out of our Temecula, CA location in the Abbott Vascular Division.  Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.  Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

WHAT YOU'LL DO

MAIN RESPONSIBILITIES

• Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Responsible for independently updating audit data and metrics in a timely manner and in accordance with business standards.

• Serve as a recognized technical expert in use of Audit Tracking tools.

• Maintain, review, and update relevant documents and records to ensure compliance and accuracy.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Collect process data from different parts of the company for analysis and including in reporting of Quality metrics as required.

• Exercises authority and judgment within defined limits to determine appropriate action.

• Support internal and external team Sharepoint sites.

• Assist and support inspection readiness and external audits, as requested.

• Works with Regulatory Compliance Management to identify process improvement initiatives within the work area.

• Plans, organizes, and prioritizes own daily work routine to meet established schedule.

• Cultivates a internal network of resources to facilitate completion of tasks.

• Support divisional quality and compliance initiatives, goals, and metrics.

• May lead a project team of moderate scope.

• Provides guidance to less experienced staff.

• Perform other duties and projects as assigned.

Minimum Experience / Training Required

Education Level

Bachelors Degree or an equivalent combination of education and work experience.  Masters Degree - Preferred

 

Experience/Background

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