Senior Compliance Auditor

Job d:
Posted 4 Days Ago

Start Date:

Location:

United States
- Illinois
- Abbott Park, United States of America Time Type:
Full time 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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty.

The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements.

We are seeking an experienced Senior Compliance Auditor with demonstrated expertise in auditing medical devices and in vitro diagnostics, including design and development controls, to ensure the protection of patient safety and compliance with applicable regulatory requirements, harmonised standards, and internal quality management system (QMS) procedures. The role involves conducting risk-based audits across the full product lifecycle, with a strong focus on quality system effectiveness, risk management activities, and adherence to global standards and regulations including ISO 13485, EU MDR/IVDR, and FDA Quality System Regulation (21 CFR Part 820) requirements.

As a Senior Compliance Auditor, you will lead Quality System audits and assessments according to regulations, standards, and Abbott procedures. You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions. The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments.

This role requires highly effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge, and skills.

Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide. Lead in-depth risk-based Quality System audits across all Abbott manufacturing sites. Plan, execute, and report Abbott manufacturing site audits. Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, EU MDR/IVDR and other applicable regulations and standards.…