Senior Quality Auditor
Abbott
Summary
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 third party supplier audits for strategic suppliers and as needed to supplement Rapid and Molecular Diagnostics Division (RMDx) BU site supplier audit programs.
Job description
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 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
- 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.
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.