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Job Information

Abbott Senior Quality Engineer - EP St. Paul in St. Paul, Minnesota

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 Senior Quality Engineer to join our EP team at our St. Paul, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is 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. This position will support new product development projects as well as support sustainability of commercially released proact. This position will support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

WHAT YOU’LL DO

  • Provide guidance to other engineers and technical mentorship to engineers, technicians, and inspectors

  • Be innovative, resourceful, and work with minimal direction

  • Work effectively with cross-functional teams

  • Lead on-time completion of new product development projects deliverables

  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions

  • Create and ensure on-time execution of Quality Plans for internal development

  • Accountable for Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities

  • Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis

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

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

  • Support internal and external audit responses and on-time product re-certifications

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

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

  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.

  • Develop and lead other team members

Other Duties:

  • Additional duties may be identified by functional management based on the current project/business objectives.

  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor’s degree in Engineering or related scientific discipline

  • 5-8+ years of related work experience (3-6+ years with relevant Master’s degree)

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

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

  • Excellent organizational, problem solving, and team leadership skills

  • 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

Preferred

  • Advanced degree in a technical field

  • Medical device experience, specifically with medical capital equipment manufacturing

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

  • Prior experience working with any or all of the following:

  • ISO 13485 Medical Devices – Quality Management System

  • 21 CFR Part 820 FDA Quality System Regulations

  • ISO 14971 Medical Devices – Application of Risk Management

  • EUMDR

  • MDSAP

  • Good Manufacturing Practices And Good Documentation Practices

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 (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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