Quality Engineer I

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.

Quality Engineer I - Plymouth, MN

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

We are recruiting for a Quality Engineer I to join our team in the Plymouth, MN location and our Electrophysiology Medical Device Division. Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in Electrophysiology, allowing people to restore their health and get on with their lives.

In this role, you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You'll Work On:

• Execute and support on-time completion of Design Control Deliverables

• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

• Accountable for Process Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activities

• Lead or support Risk Management activities from product Concept through Commercialization

• Support process test and inspection method development, and lead method validation activities

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Support manufacturing process development & qualification for new product commercialization and product changes

• Support internal & external audit responses

• Support product re-certifications

• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements

• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications

• Support execution of biocompatibility and sterilization qualifications

• Complete Document Change Request Reviews in a timely and objective manner

Required Qualifications

• Bachelor's Degree in Engineering, Sciences, or related discipline.

• 0-2+ years of related work experience.

• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.

• 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.

• Multitasks, prioritizes, and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 10%, including internationally.

• Ability to maintain regular and predictable attendance.

Preferred Qualifications

• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies

• Prior medical device experience

• Experience working in a broader enterprise/cross-division business unit model

• ASQ Certified Quality Engineer / Six Sigma Green Belt Certification

• Working understanding of FDA, GMP, and ISO 13485

• Working understanding of the following standards 60601, 62304, &/or 14971

• 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 X @AbbottNews.

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.