Senior Quality Auditor

Regulatory Toolkit; Lake Forest (IL); Sur place; USD 87 000 - 173 000; Plein temps

Avantages offerts par ce poste

Free medical coverage (HIP PPO) in the

Great retirement savings plan

Tuition reimbursement

Freedom to Save education benefit

Diversity and recognition programs

Résumé du poste

Abbott in Lake Forest, IL, is seeking a Senior Quality Auditor to lead the Infectious Disease BU audit program and perform internal and supplier audits across regions. The role requires deep regulatory knowledge, robust auditing experience, and collaboration with global quality teams.

You will develop audit standards, train auditors, and drive corrective actions to ensure cGMP, ISO 13485, and MDR/IVDR compliance while supporting cross-site audits and travel up to 60% as needed.

Qualifications

• Bachelor’s degree in science, engineering, pharmaceuticals or equivalent.
• 8+ years total experience with at least 3 years in quality in medical device industry, including Quality Systems Auditor.
• In-depth knowledge of QSR, ISO 13485, MDSAP, cGMP, MDR/IVDR and related standards.

Responsabilités

• Develop and execute Infectious Disease BU audit program for Abbott RMDx.
• Perform internal audits of sites and suppliers; support cross-site audits.
• Lead audit schedule, prepare, conduct, and issue final audit reports.
• Train and mentor ID BU auditors; support corrective actions and root-cause analysis.
• Collaborate with local site Quality teams to maintain compliance.

Connaissances

Quality Auditor

Regulatory compliance

Auditing standards

Communication skills

Formation

Bachelor’s Degree in Science/Engineering/Pharma

Outils

MS Word

MS Excel

PowerPoint

Description du poste

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 Lake Forest, IL location in the Rapid and Molecular Diagnostics Division (RMDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The Senior Quality Auditor is responsible for developing and executing the Infectious Disease (ID) Business Unit (BU) audit program that ensures performance of independent internal compliance audits for RMDx entities (including affiliates) and suppliers as required. Duties will principally be within his/her region, but it will be necessary to support activities in other geographic regions. The Senior Quality Auditor shall also be responsible for performing thirdparty supplier audits for strategic suppliers and as needed to supplement Rapid and Molecular Diagnostics Division (RMDx) BU site supplier auditprograms.

What You’ll Work On

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation, and effectiveness of applicable QualityProcesses as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associatesreflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur fromthe improper performance of their specific job.
• Perform other duties and projects as assigned.
• Execute ID internal audit schedule. Collaborate with other Quality System Auditors to develop and maintain ID BU audit standards andprocedures.
• As applicable, engage local site Quality teams in audit program, utilizing local qualifiedauditors/resources to perform cross-site audits, ensuring annual independent review of each site’s qualitysystem processes.
• Perform audits, including preparation, conduct, and issuance of final audit report.
• Assist with quality auditor training program, to assess and develop ID BU auditors throughtraining and mentorship.
• Support sites as required in prioritizing and correcting audit findings, including training, processdevelopment, additional directed audits, and providing on-site support.
• Support ID BU leadership as necessary through assigned tasks and projects.

Required Qualifications

• Bachelor’s Degree in Science, Engineering, pharmaceuticals or equivalent.
• Minimum 8 years of experience with at least 3 years Quality work experience in medical device industry,including experience as a Quality Systems Auditor, and competent working knowledge of nationallyrecognized Quality Management System auditing standards and procedures.
• In depth knowledge of and ability to apply quality system regulation including QSR, ISO 13485, MDSAP,cGMP Regulations, MDR and IVDR and other regulations and standards relevant to the ARDx business.

Preferred Qualifications

• Certification as a Quality Auditor from ASQ, RAPS, ISO or equivalent.
• General knowledge of engineering and technical applications applied in development of medical devicesis useful.
• Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
• Excellent interpersonal, written and verbal communication skills, including ability to make clear, well-founded decisions regarding conformity during audits.
• Ability to travel, including valid driver’s license (60% travel a requirement) and passport.

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:

ID Infectious Disease

LOCATION:

United States > Lake Forest : J55

WORK SHIFT:

Standard

TRAVEL:

Yes, 50 % 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), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneelingAbbott 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.pdfEEO 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.