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.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 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 Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Quality Engineer I, 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.  You will support new product development projects as well as support sustainability of commercially released product. You may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

Responsibilities

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 requirementsLead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsAssist in the development and execution of streamlined business systems which effectively identify and resolve quality issuesApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesDesign and conduct experiments for process optimization and/or improvementAppropriately document experiment plans and results, including protocol writing and reportsLead process control and monitoring of CTQ parameters and specificationsLead 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-conformancesParticipate 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 analysisWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesSupport 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.

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required 

Bachelor’s degree in engineering or Technical Field or an equivalent combination of education and work experience0-2 years Engineering experience and demonstrated use of quality tools/methodologies.  Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Risk management, post market surveillance, and manufacturing analysisAbility to work in a highly matrixed and geographically diverse business environmentAbility to work within a team and as an individual contributor in a fast-paced, changing environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMultitasks, prioritizes, and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detail

Preferred 

Prior medical device experience preferredExperience working in a broader enterprise/cross-division business unit model preferredCAPA owner or a key cross-functional team member leading a CAPA project

Apply Now

 

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 $50,000.00 – $100,000.00. In specific locations, the pay range may vary from the range posted.