Specialist Quality Assurance

Abbott (abbottcareers2 board); Saint Paul (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott, a global healthcare leader, seeks a Supplier Quality Engineer for the Vascular division in New Brighton, MN. This fully onsite role supports Third Party Manufacturing, supplier qualification, and regulatory compliance within a quality system environment.

The position emphasizes collaboration across Design, Manufacturing, Purchasing and IQA, strong problem-solving, and the ability to navigate ISO/QSR requirements to ensure robust supplier quality.

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.

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.

Skills

Analytical thinking

Problem solving

Communication

Education

Bachelor's degree

Tools

GMP inspections

Quality systems

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 DESCRIPTION

Job Description

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.

JOB FAMILY: Operations Quality

DIVISION: AVD Vascular

LOCATION: United States > Minnesota > St. Paul : 1225 Old Highway 8 NW

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/P