Senior Quality Auditor
About The Position
The Senior Quality Auditor works at Abbott’s Lake Forest, Illinois location in the Rapid and Molecular Diagnostics Division (RMDx), part of Abbott’s Diagnostics businesses. The role develops and executes the Infectious Disease (ID) Business Unit audit program, conducting independent internal compliance audits for RMDx entities, affiliates, and suppliers as required. Duties are primarily within the auditor’s region, with support for activities in other geographic regions as needed. The position also performs third-party audits of strategic suppliers and supplements RMDx Business Unit site supplier audit programs. The auditor executes the ID internal audit schedule, performs audits from preparation through final report issuance, helps maintain audit standards and procedures, and supports auditor training and mentorship. The role also works with sites to prioritize and correct audit findings, providing training, process development, additional audits, and on-site support as needed. The position operates in accordance with company policies and applicable quality processes and regulations.
Requirements
- Bachelor’s degree in science, engineering, pharmaceuticals, or equivalent.
- At least 8 years of experience, including at least 3 years of Quality work experience in the medical device industry.
- Experience as a Quality Systems Auditor.
- Competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
- In-depth knowledge of and ability to apply quality system regulations and standards, including QSR, ISO 13485, MDSAP, cGMP Regulations, MDR, IVDR, and other regulations and standards relevant to the ARDx business.
- Ability to travel, including holding a valid driver’s license and passport; travel is a 60% requirement.
Nice To Haves
- Certification as a Quality Auditor from ASQ, RAPS, ISO, or equivalent.
- General knowledge of engineering and technical applications used in medical device development.
- Proficiency with MS Word, Excel, PowerPoint, and spreadsheet management.
- Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded conformity decisions during audits.
Responsibilities
- Execute the Infectious Disease Business Unit internal audit schedule.
- Collaborate with Quality System Auditors to develop and maintain ID Business Unit audit standards and procedures.
- Engage local site Quality teams and qualified local auditors or resources to conduct cross-site audits and ensure annual independent review of each site’s quality system processes.
- Perform audits, including preparation, conduct, and issuance of final audit reports.
- Assist with the quality auditor training program by assessing and developing ID Business Unit auditors through training and mentorship.
- Support sites in prioritizing and correcting audit findings through training, process development, additional directed audits, and on-site support.
- Perform third-party supplier audits for strategic suppliers and supplement RMDx Business Unit site supplier audit programs as needed.
- Support ID Business Unit leadership through assigned tasks and projects.
- Carry out duties in compliance with established business policies and procedures.
- Demonstrate commitment to the development, implementation, and effectiveness of applicable quality processes under ISO, FDA, and other regulatory agencies.
- Maintain professional conduct with internal and external business associates consistent with company policies and practices.
- Understand and maintain awareness of quality consequences that may result from improper performance of the role.
- Perform other duties and projects as assigned.
Benefits
- Career development opportunities with an international company.
- Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- Retirement savings plan with a high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit providing an affordable and convenient path to a bachelor’s degree.
- Health and wellness benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
