Senior Software Risk and Compliance Auditor

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, 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 DESCRIPTION:

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’ll also have access to opportunities described below.

• 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 recognized as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our corporate Abbott Park, Illinois location or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbott's 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 with 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 Software Risk and Compliance Auditor with specialized expertise in auditing medical device software to protect patient safety and ensure compliance with regulatory requirements, industry standards, and internal policies. This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.

As a Senior Software Risk and 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.

The role requires very 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 with focus on Product and Non Product Software including apps across Abbott manufacturing sites
• Plan, execute, and report on internal audits including in-depth analysis on medical device software development and validation processes.
• Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IEC 62304, GAMP 5 CSV and other applicable regulations and standards.
• Monitor emerging regulatory requirements, industry…