Quality Engineer I at Abbott Laboratories

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.

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

This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Quality Engineer I, you’ll be 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:

• Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.
• Will be responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
• Will conduct inspection, verification and validation of components or materials used in development processes.
• Able to identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Will document quality issues and performance measures for management review.
• May liaise with external vendors.
• 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

Required Qualifications:

• BS degree in Engineering, or technical diploma + equivalent experience

Preferred Qualifications:

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Prior medical device experience
• Experience working in a broader enterprise/cross-division business unit model
• Advanced computer skills, including statistical/data analysis and report writing skills
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $48,000.00 – $96,000.00. In specific locations, the pay range may vary from the range posted.