R&D Quality Engineer

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 109,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS:

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 109,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve. Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Our location in Abbott Park (Waukegan, Illinois) currently has an opportunity for a R&D Quality Engineer.

WHAT YOU'LL DO

Main Responsibilities:

• Product development core team member responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development.
• Analyzes, develops, and recommends quality engineering approaches required to meet design and production requirements. Compiles and evaluates design and test data, identifies key product, process, or material factors and determines appropriate limits and specifications. Reviews, generates, and approves related inputs such as process / test method characterization and applies this information to specification development. Prepares and assesses failure mode analysis and control plans.
• Strong documentation skills. Has flexibility to work in an FDA regulated environment with an understanding of the associated documentation requirements and is familiar with FDA regulations and standards. Responsible for adhering to the quality system and good manufacturing procedures.
• Plans and performs assignments of a wide degree of difficulty. Analyzes, develops, and recommends quality engineering approaches required to meet design and production requirements. Compiles and evaluates design and test data and identifies key product, process, or material factors and determines appropriate limits and specifications. Prepares and assess failure mode analysis and control plans.

Position Accountability/Scope:

• Receives general direction and exercises considerable discretion as to personal work details.
• Reviews, generates, and approves related inputs such as FMEAs and specifications.
• Coordinates activities with other areas.
• May provide input on potential candidates to be hired into the team.
• Interfaces with product team members, manufacturing quality and medical affairs.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• Bachelor's degree in a related field; or an equivalent combination of education and work experience. Master's degree preferred.
• Minimum 3 years related work experience with a good understanding of specified functional area.
• Good organizational and project management skills.
• Ability to work independently and in groups; ability to work cross-functionally; ability to prioritize.
• Working technical knowledge and application of concepts, practices and procedures.
• Good understanding of business unit/group function and cross group dependencies/relationships.
• Will perform this job in a quality system environment; failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Demonstrated initiative and problem-solving skills; critical-thinking skills.
• Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Preferred

• Medical device or IVD industry experience is ideal
• One to two years of IVD Quality Engineering work experience in: (i) analyzing, developing, and recommending quality engineering approaches required to meet design and production requirements; (ii) compiling and evaluating design and test data and identifying key product, process, or material factors and determining appropriate limits and specifications (iii) creating risk analyses and Failure Mode and Effects Analyses (FMEAs).
• Experience / training in electronic data management, data mining and analytics, test method and process characterization protocol development, design verification / validation analysis also preferred.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.