Quality Engineer II

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:

Quality Engineer II

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

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.

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
• 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
• 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.

Required Qualifications

• Bachelor’s degree in Engineering or Technical Field/related degree.
• 2-5 years of engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO, 13485, and ISO.
• Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced compute