Quality Auditor
: Job Details :

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 114,000 colleagues serve people in more than 160 countries.

Job Title: Quality Auditor

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. Youll 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 bachelors 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

The Quality Auditor is responsible for developing and executing the ID BU audit program to ensure the performance of independent internal compliance audits for RMDx entities (including affiliates) and suppliers as required. While duties will primarily be within their region, support for activities in other geographic regions will also be necessary. The Quality Auditor will perform third-party supplier audits for strategic suppliers and supplement RMDx BU site supplier audit programs as needed. This job description will be reviewed periodically and is subject to change by management.

What Youll Work On

• Comply with established business policies and procedures.
• Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the companys policies and practices.
• Understand and maintain awareness of the quality consequences that may result from improper performance of specific job duties.
• Perform other duties and projects as assigned.
• Execute the ID internal audit schedule.
• Collaborate with other Quality System Auditors to develop and maintain ID BU audit standards and procedures.
• Engage local site Quality teams in the audit program, utilizing local qualified auditor resources to perform cross-site audits, ensuring annual independent review of each sites quality system processes.
• Perform audits, including preparation, conduct, and issuance of final audit reports.
• Assist with the 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.
• Proactive attitude, excellent organizational skills, and ability to manage multiple projects while delivering results on time.
• Ability to travel, including a valid drivers license (60% travel required) and passport.
• General knowledge of engineering and technical applications applied in the development of medical devices is useful.

Required Qualifications

• Bachelors Degree in Science, Engineering, or an equivalent field.
• Certification as a Quality Auditor from ASQ, RAPS, ISO, or an equivalent organization.

• Proficient in MS Word, Excel, PowerPoint, and spreadsheet management.
• In-depth knowledge of and ability to apply quality system regulations, including QSR, ISO 13485, MDR, IVDR, MDSAP, and other relevant regulations and standards for the RMDx business.
• Minimum of 8 years of experience, with at least 3 years in Quality within the medical device industry, including experience as a Quality Systems Auditor.
• Competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
• Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded decisions regarding conformity during audits.

Apply Now

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

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 www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $85,300.00 $170,700.00. In specific locations, the pay range may vary from the range posted.