Specialist Quality Assurance

Abbott; Saint Paul (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

HIP Medical plan

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Supplier Quality Engineer for the Vascular division in New Brighton, MN. This is a fully onsite role focused on supplier quality, GMP, ISO/QSR compliance, and cross-functional collaboration with manufacturing, IQA, and design teams.

Responsibilities include qualifying third-party manufacturers, monitoring supplier performance, investigating field failures, and driving corrective actions within a quality system framework.

Qualifications

• 0-2 years related work experience with a good understanding of the specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Responsibilities

• Support Third Party Manufacturing, perform GMP inspections, 5S, and execute STOP process.
• Support commercial launch at Third Party Manufacturer.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
• Analyzes and solves problems from basic engineering principles, theories, and concepts through to a wide range of complex problems.
• Incorporates business policies and procedures into task completion.
• Understands the business needs of the company and has knowledge of the customer needs of our business.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Analyzes incoming material defects.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials.
• Develop corrective action plan where necessary. Dispositions and drives corrective action as necessary..
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Education

Bachelor's Degree in a related field

Job description

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 122,000 colleagues serve people in more than 160 countries.

Job Title

Supplier Quality Engineer

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 of which you dream.
• 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

We currently have an opening for a Supplier Quality Engineer for the Vascular division. This role is located at our New Brighton, MN location. This is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Main Responsibilities

• Individual will support Third Party Manufacturing, perform GMP inspections, 5S, and execute STOP process.
• Support commercial launch at Third Party Manufacturer.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
• Analyzes and solves problems from basic engineering principles, theories, and concepts through to a wide range of complex problems.
• Incorporates business policies and procedures into task completion.
• Understands the business needs of the company and has knowledge of the customer needs of our business.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Analyzes incoming material defects.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials.
• Develop corrective action plan where necessary. Dispositions and drives corrective action as necessary..
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Education And Experience You’ll Bring

Minimum Education

• Bachelors Degree in a related field or an equivalent combination of education and work experience

Required Qualifications

• 0-2 years related work experience with a good understanding of specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

The base pay for this position is $61,300.00 - $122,700.00. In specific locations, the pay range may vary from the range posted.