Project Manager, Quality

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.

We currently have an opportunity for a Project Manager - Quality which can be based out of our New Brighton, MN or Temecula, CA locations.

THIS IS AN ONSITE DAILY ROLE - NO REMOTE.

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL BASED ON EXPERIENCE/SKILLS.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

  

The Opportunity

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 Work On

Job Summary:

Provides guidance for the assessment and integration of CSI and AV Quality Management Systems.  Works closely with regulatory compliance, quality and key process owners to complete the assessment, project plan and drive the execution of the integration. 

WHAT YOU'LL DO

• Interfaces with cross-functional resources to ensure all key processes are adequately assessed and create overall plan for integration.
• Create and manage Quality plan(s) to drive integration and be SME for plan
• Identify process dependencies and work with SMEs to ensure these dependencies are accounted for integration plan
• Work with management to identify SMEs and manage sub-project teams
• Provides quality system guidance for applicable process and procedure changes.
• Participates and prepares updates for review boards, business unit planning, and others as necessary.
• Manage project plan and hold functional area SMEs accountable to commitments and project schedule
• Provides project updates to Executive Management and Project Steering Committee
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Equipment:

Works with standard office equipment, telephone, cellular phone, and personal computer. Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline travel.

        

Working Conditions:

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a signific