Quality Engineer

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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 more than 160 countries.

• 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.

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision‑making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

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.

In addition:

• Identify, review, and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation / resolution.
• Lead in the review and/or implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Assist in the review, 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.
• Appropriately document experiment plans and results, including protocol writing and reports.
• Draft and review the CTQ parameters and specifications.
• 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).

• Bachelor’s degree in Science, Engineering or a closely related discipline.
• More than 2 years' Engineering experience and demonstrated use of Quality tools/methodologies.
• 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 computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross‑division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability…