Senior Specialist Quality Assurance - Supplier Quality

Abbott; Des Plaines (IL); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Career development

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefit - FreeU

Great place to work

Job summary

Abbott in Des Plaines, IL, within the Abbott Molecular Diagnostics Division, is hiring a Senior Specialist Quality Assurance - Supplier Quality to oversee supplier selection, approval, and ongoing performance. You will conduct audits across supplier networks, strengthen quality systems, mentor auditors, and drive improvements aligned with 21 CFR 820, ISO 13485, GMPs and other global standards.

The role requires cross-functional collaboration, project leadership, and ensuring regulatory

Qualifications

• Bachelor's degree required; degree in a related field preferred.
• Minimum 7 years of quality or related field experience; advanced degree may reduce experience needs.

Responsibilities

• Independently conducts and leads audits across supplier and TPM network.
• Maintain and strengthen Quality System effectiveness by ensuring adherence to regulatory requirements, site procedures, and corporate quality policies.
• Provides guidance and trains colleagues, provides mentoring to junior auditors.
• Participates as SME in audits, provides compliance and strategic solutions to complex quality issues.
• May lead cross-functional projects and champion new initiatives.
• Maintains understanding of global standards, regulations, and regulatory bodies.
• May assume managerial responsibilities as needed.
• Mentor less senior members of the group.
• Develop innovative, compliant solutions to quality challenges and drive business results.

Skills

Quality management

Auditing

Leadership

Regulatory interpretation

Education

Bachelor's Degree

Tools

GMPs

ISO 13485

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.

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 Des Plaines, IL location in the Abbott Molecular, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Senior Specialist Quality Assurance - Supplier Quality will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

What You’ll Work On

• Independently conducts and leads audits across supplier and TPM network.
• Maintain and strengthen Quality System effectiveness by ensuring adherence to regulatory requirements, site procedures, and corporate quality policies.
• Provides guidance and trains colleagues, provides mentoring to one or more junior level auditors.
• Participates as SME in audits, provides compliance, and strategic solutions to complex quality issues.
• May lead projects that are cross-functional in scope, directly influence project direction and scope, champions new initiatives and acts as the catalyst for change.
• Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies.
• May assume managerial responsibilities as needed.
• May mentor less senior level members of the group
• Develop innovative, compliant, and practical solutions to complex quality challenges that support organizational goals and operational excellence.
• Communicate effectively with management, suppliers, and cross-functional partners to drive project direction, quality strategy, and business results.

Required Qualifications

• Bachelors Degree
• Minimum 7 years in Quality or related field experience; Less experience may be appropriate with advanced degree.

Preferred Qualifications

• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.
• Certified ISO Lead Auditor qualification or equivalent is required. Excellent written and verbal communication skills.

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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.