Job Information
Abbott Senior Engineer, Quality 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 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.
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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 seeking a Senior Quality Engineer to join our EP team at our St. Paul, MN location. 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.
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 Work On
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
Required Qualifications
Bachelor’s degree in Engineering or related scientific discipline5-8+ 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
Preferred Qualifications
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 System21 CFR Part 820 FDA Quality System RegulationsISO 14971 Medical Devices – Application of Risk ManagementEUMDRMDSAPGood Manufacturing Practices And Good Documentation Practices
Apply Now (https://www.jobs.abbott/us/en)
- 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 (http://www.abbottbenefits.com/pages/candidate.aspx)
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 $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
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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