Sr. Supplier Quality Engineer

Thornton Tomasetti; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Supplier Development Quality Engineer for the Structural Heart division in Minnesota. The role focuses on supplier selection, qualification, and quality assurance, ensuring regulatory compliance and robust supplier performance.

Ideal candidates have 5+ years in medical device quality, strong leadership, and experience with SAP and Six Sigma. The role requires on-site work in New Brighton, MN with occasional travel.

Qualifications

• Minimum 5 years of related experience in supply chain, planning, or operations with medical device context.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with SAP and maintaining master data integrity.
• Proven project management and leadership capabilities.
• Advanced data analysis and report-writing skills.

Responsibilities

• Develop and maintain supplier quality program policies, procedures, and forms.
• Coach and mentor technical teams in applying program requirements.
• Provide guidance to Purchasing, R&D, Manufacturing, and Quality engineers.
• Review and approve supplier drawings and quality plans.
• Develop inspection procedures and first article requirements.
• Provide engineering guidance to Receiving Inspection including Gage R&R studies.
• Assess supplier capabilities through visits and audits.
• Communicate quality issues to suppliers and track corrective actions.
• Lead supplier performance reviews and data partnerships.
• Apply systematic problem-solving to reduce inspection needs.

Skills

Quality engineering

FDA regulations

GMP

ISO 13485

ISO 14971

Six Sigma

Lean Manufacturing

Data analysis

Project management

Leadership

Education

Engineering degree

Tools

SAP

Quality systems tooling

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 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our New Brighton, MN location on our Structural Heart team.

Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.

Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.

What You’ll Work On

• Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.
• May provide coaching and mentoring for technical team personnel.
• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
• Reviews and approves all supplied product drawings and component quality plans.
• Manages development of supplied product inspection procedures and first article requirements.
• Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
• Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
• Contributes and participates in supplier performance reviews.
• Evaluates and develops Supplied Data Agreement partnerships with suppliers.
• Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
• Works with Manufacturing engineering to assess and address purchased product issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Design and conduct experiments for process optimization and/or improvement
• Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
• 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

Minimum 5 years of related experience in supply chain, planning, or operations. Medical device industry experience preferred. Demonstrated supervisory or leadership experience. Background in engineering and use of quality tools/methodologies. Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971. Experience with SAP and maintaining master data integrity. Solid communication and interpersonal skills. Proven project management and leadership capabilities. Advanced computer skills including data analysis and report writing. Experience with Six Sigma, Lean Manufacturing, or other improvement methodologies.

Preferred Qualifications

ASQ CQE or other relevant certifications preferred. ISO 13485 auditing experience preferred. Experience working in a cross-divisional or enterprise-level business model. Ability to thrive in a matrixed and geographically diverse environment. Strong team collaboration and individual contributor skills. Ability to engage and influence others to accomplish goals. Effective communication across multiple organizational levels. Willingness to potentially travel 10%, including internationally.

The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: SH Structural Heart LOCATION: United States > Minnesota > St. Paul : 1225 Old Highway 8 NW ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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