Engineer II Quality Systems

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:

Engineer II Quality Systems

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.

The Opportunity

We are currently seeking a highly capable Engineer II Quality Systems to support Abbott’s Structural Heart (SH) Division at our Westfield, IN location. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

In this role, you will establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances and standards (LRGS).

What You’ll Work On

• Identify internal requirements and external laws, regulations, guidances and standards (LRGS) applicable to one or more of Abbott's quality systems.
• Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in Abbott business processes.
• Identify areas of potential noncompliance within Abbott.
• Review and update the Quality System Manual as needed.
• Educate functional areas on quality system requirements.
• Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
• Mediate resolution of interdepartmental and cross business unit process conflicts.
• Identify qualified external consultants and experts in government, collaborating with them to insure correct interpretation of LRGS.
• Collect business process data from different parts of the company for analysis.
• Act as an expert resource in specific LRGS requirement knowledge for Abbott.
• May be responsible for identifying training requirements, programs, and tracking systems.
• Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
• May demonstrate basic project management skills by acting as a project lead on small, well defined projects.
• Provides guidance to less experienced staff.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
• Owns and facilitates site Quality System by collaborating with nonconformance/CAPA owners to ensure robust, compliant CAPAs and compliance with Abbott’s timeliness requirements.
• Provide resource and strategy support during internal and external compliance audits and inspections, including leading audit resource team, managing logistics, lea