Sr. Supplier Development Quality Engineer

Abbott; Saint Paul (MN); On-site; USD 75,000 - 151,000; Full time

Job summary

An established industry player in healthcare is seeking a Senior Supplier Development Quality Engineer to enhance quality and compliance in their Structural Heart division. In this pivotal role, you will leverage your expertise to manage supplier relationships, develop quality requirements, and ensure the highest standards for new product initiatives. You will play a key role in assessing suppliers, generating inspection procedures, and analyzing material defects, all while working in a dynamic and collaborative environment. This opportunity not only allows you to make a significant impact on patient care but also offers a pathway for professional growth and development within a respected global organization.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Flexible work environment

Career development opportunities

Qualifications

• 5+ years of experience in supplier quality management in medical devices.
• Strong understanding of FDA, GMP, and ISO standards.

Responsibilities

• Manage supplier relationships and assess new suppliers' capabilities.
• Develop incoming inspection procedures and train inspectors.
• Analyze incoming material defects and communicate issues.

Skills

Quality tools/methodologies

FDA regulations

GMP standards

ISO 13485

ISO 14971

Technical analysis

Project management

Education

Bachelor's Degree in related field

Tools

Inspection tools and equipment

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 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:

1. Career development with an international company where you can grow the career you dream of.
2. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
3. An excellent retirement savings plan with high employer contribution.
4. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
5. 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.
6. 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. 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 Senior Supplier Development Quality Engineer, you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support in the selection of suppliers and developing acceptance criteria for materials.

What You’ll Work On

1. Assess potential new suppliers for technical, quality and manufacturing capabilities.
2. Provides technical support for the introduction of components from a new supplier.
3. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
4. Develops and/or sources inspection tools and equipment.
5. Assists in generating component specifications.
6. Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
7. Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
8. Analyzes incoming material defects.
9. Communicates issues internally and with suppliers.
10. Reviews new design specifications and provides input from component quality and manufacturability perspective.
11. Work with internal and external stakeholders to qualify supplier processes.
12. Develops and validates inspection methods for new components.
13. May supervise inspectors.
14. Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
15. Plans, organizes, and prioritizes own daily work routine to meet established schedule.
16. Exercises authority and judgment within defined limits to determine appropriate action.

Qualifications

1. Bachelors Degree in related field.
2. 5+ years of related work experience with a good understanding of specified functional area.
3. Prior medical device experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
4. Working technical knowledge and application of concepts, industry regulations and best practices.
5. 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.
6. Ability to lead projects 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.
7. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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 $75,300.00 – $150,700.00. 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 [e-mail]