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.
Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.
We are seeking a passionate Quality Engineer to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will be involved in nonconformance and complaint investigation management, including root cause problem solving and providing event information to our various business partners (e.g. Regulatory, Quality Engineering).
WHAT YOU’LL DO
· Follows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott engineering standards, and other governance areas as applicable.
· Implements and maintains the effectiveness of the Quality System.
· Identifies areas of risk with respect to compliance to internal and external requirements.
· Completes Non-conformance, CAPA, and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages.
· Influences key partners to develop and maintain QA procedures, forms, and systems.
· Leads meetings and communications for QA system information, concerns, and updates.
· Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Abbott goals.
· Follows 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.
· Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
· Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
· 2-5 years technical experience
· Previous Quality assurance/engineering experience and use of Quality tools/methodologies
· Good communication and interpersonal skills
· Advanced computer skills, including statistical/data analysis and report writing skills
· Ability to work within a team and as an individual contributor in a dynamic, changing environment.
· Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
· Multitasks, prioritizes and meets deadlines in timely manner.
· Excellent organizational and follow-up skills, as well as attention to detail.
· Detailed knowledge of FDA, GMP, and ISO 13485 preferred
· ASQ CQT, CQE, CQA certification preferred
· Six Sigma root cause analysis/problem solving training and experience preferred.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
· A fast-paced work environment where your safety is our priority
· Production areas that are clean, well-lit and temperature-controlled
· 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.
EPHF Electrophysiology & Heart Failure
United States > Minnesota > Plymouth : 5050 Nathan Lane N
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf