Senior Quality Auditor

United States - Illinois - Lake Forestsenior

OtherQuality Auditor

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Quick Summary

Overview

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,

Technical Tools

OtherQuality Auditor

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.

What We Offer

~2 min read

✓Carries out duties in compliance with established business policies and procedures.

✓Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

✓Responsible for exhibiting professional behavior with both internal/external business associates reflects 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 from the 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 and procedures.

✓As applicable, engage local site Quality teams in audit program, utilizing local qualified auditors/resources to perform cross-site audits, ensuring annual independent review of each site’s quality system 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 through training and mentorship.

✓Support sites as required in prioritizing and correcting audit findings, including training, process development, additional directed audits, and providing on-site support.

✓Support ID BU leadership as necessary through assigned tasks and projects.

Requirements

~1 min read

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 nationally recognized 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.

Certification as a Quality Auditor from ASQ, RAPS, ISO or equivalent.
General knowledge of engineering and technical applications applied in development of medical devices is 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.

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Operations Quality

ID Infectious Disease

United States > Lake Forest : J55

Standard

Yes, 50 % of the Time

Not Applicable

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 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