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Quality System 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 113,000 colleagues serve people in more than 160 countries.

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

**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**

This position works out of our St. Paul, MN location in the Structural Heart division.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Quality System Engineer I, you'll be responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).

**What You’ll Work On**

+ Provides Quality System Body of Knowledge support to Division and organization.

+ Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.

+ Investigates and resolves system nonconformance’s (defined during internal and/or external audits.

+ Works with product development and production engineers during product development process to ensure quality deliverables (FMEA, Control Plans, Risk Management) are in place prior to Design Transfer phase gate.

+ Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.

+ Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

+ As appropriate, utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.

+ Analyzes quality audit findings and recommends modifications in products or standards.

+ Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.

+ As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the

+ Quality System function as a Team Member)

+ As appropriate, participate in or lead in the completion and maintenance of risk analysis, as related to quality systems.

+ Performs other duties as assigned.

+ 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.

**Required Qualifications**

Bachelor’s Degree plus 8 years In Engineering or Technical Field.

+ 2-5 years technical experience.

+ Previous Quality experience and demonstrated use of Quality tools/methodologies.

+ Detailed knowledge of FDA, GMP, and ISO 13485.

+ Solid communication and interpersonal skills.

+ Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.

+ Advanced computer skills, including gap analysis and report writing skills.

+ Prior medical device experience preferred.

+ Six Sigma certification preferred.

+ ASQ CQE, CQA certification preferred.

+ Experience working in a broader enterprise/cross-division business unit model preferred.

+ 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.

+ Strong verbal and written communications with ability to effectively communicate at

+ multiple levels in the organization.

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

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

+ Ability to travel approximately 10-25%, including internationally.

* 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:** (

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 , on Facebook at 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

Quality System Engineer I

Full time
St Paul, MN

Published on 09/18/2022

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