Quality Engineer II

Abbott • Westfield, IN

1d

About The Position

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 115,000 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 your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our NorthPoint Westfield, IN location in the Structural Heart Division Structural Heart Business Mission: Why We Exist 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. 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.

Requirements

• Bachelors Degree in Engineering or related field.
• 2–5 years of engineering experience with demonstrated use of quality tools/methodologies; strong knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Proven ability to support cross-functional, multi-department project teams, resolve quality issues effectively, and operate within a highly matrixed, geographically diverse organization.
• Advanced computer skills including statistical/data analysis, reporting, and data-driven decision-making.
• Strong verbal and written communication skills across all organizational levels; highly organized, detail-oriented, able to multitask, prioritize, and meet deadlines in a fast-paced environment.

Nice To Haves

• Medical device experience preferred
• Six Sigma, Lean Manufacturing, and ASQ CQE certification a plus.

Responsibilities

• 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
• Lead 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 non-conformances
• 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
• 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.

Benefits

• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees