Senior Specialist Quality Assurance - Supplier Quality

Regulatory Toolkit; Des Plaines (IL); Vor Ort; USD 87.000 - 173.000; Vollzeit

Benefits dieser Stelle

HIP PPO medical plan

Retirement plan with employer match

Tuition reimbursement / FreeU program

Zusammenfassung

Abbott Molecular in Des Plaines, IL is seeking a Senior Specialist Quality Assurance - Supplier Quality to drive supplier qualification, approvals, and ongoing performance monitoring. You will ensure compliance with US and international quality requirements while leading audits across the supplier network.

The role involves mentoring junior auditors, guiding quality improvements, and collaborating with cross-functional teams to implement robust corrective actions and preventive measures.

Qualifikationen

• Bachelor's degree in a related field.
• 7+ years in Quality or related field; less experience may be appropriate with an advanced degree.
• Excellent written and verbal communication skills.

Aufgaben

• Independently 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.
• Leads cross-functional projects, champions new initiatives, and acts as catalyst for change.
• Maintains understanding of global standards, regulations, and regulatory bodies.
• May mentor less senior members of the group.
• Develop innovative, compliant, and practical solutions to complex quality challenges.
• Communicate effectively with management, suppliers, and cross-functional partners to drive project direction and business results.

Kenntnisse

Auditing

Quality systems

Regulatory knowledge

Mentoring

Project leadership

Ausbildung

Bachelor's Degree

Jobbeschreibung

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 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.

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.

JOB FAMILY:

Operations Quality

DIVISION:

AMD Molecular

LOCATION:

United States > Des Plaines : DP01

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

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), Work requiring repeated bending, stooping, squatting or kneeling

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

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.

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