Quality Engineer I

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:

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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• 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.

The Opportunity

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

What You’ll Work On

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

• Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues

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

• Design and conduct experiments for process optimization and/or improvement

• Appropriately document experiment plans and results, including protocol writing and reports

• Lead process control and monitoring of CTQ parameters and specifications

• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

• Lead the investigation, resolution and prevention of product and process nonconformances

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

• Lead in the completion and maintenance of risk analysis

• Work with design engineering in the completion of product verification and validation

• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), 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.

• May assist in the training of personnel as directed by management.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree Or an equivalent combination of education and work experience

• Eng