Abbott · 21 hours ago
Senior Software Risk and Compliance Auditor
Illinois, United States
Full-time
Onsite
Senior Level, Lead/Staff
$129K/yr - $259K/yr
10+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Software Risk and Compliance Auditor with specialized expertise in auditing medical device software to ensure compliance with regulatory requirements and industry standards. The role involves conducting audits, evaluating compliance, and communicating risks to management.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
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 indepth analysis on medical device software development and validation processes
Evaluate compliance with global redulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IEC 62304, GAMP5 CSV and other applicable regulations and standards
Monitor emerging regulatory requirements, industry trends and competitor analysis to develop audit strategies and identify products or process which require focused audits
Maintain up-to-date knowledge of evolving regulations and best practices in medical device software compliance
Review software documentation, risk management files, and validation protocols for technical completeness and compliance
Identify non-conformities, product and process risks, and areas for improvement
Write professional audit reports for executive management
Communicate effectively to articulate risks and associated impact to all levels of management
Develop and provide professional edication on compliance and quality topics that are key to Abbott businesses
Develop risk based audit program with oversight for auditing of product and non product software including development of Abbott wide auditor training and competency assessments
Analyse compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers
Promotes and apply best-practice analysis and auditing tools, understanding their constraints, advantages, and disadvantages, and ensuring adherence to established standards
Promote continuous learning and improvement within the audit team
Qualification
Required
Four-year degree in a scientific, technical or compliance discipline or equivalent experience
Lead auditor certificate for Quality System audits desirable
In-depth knowledge of global software standards and regulations including IEC 62304, ISO 13485, ISO 14971, GAMP 5 CSV and FDA software validation guidance
Strong analytical and problem-solving skills with attention to detail
Very effective oral and written communication, critical thinking and decision making skills
Ability to manage multiple audits and prioritize effectively
Proficiency in audit tools and techniques; certifications such as ISO Lead Auditor are desirable
Effective time management skills
Preferred
10+ years in software design and development in the medical device industry
Proven track record working on software development and software lifecycle programs including : Software as a medical device, Software within a medical device, Cloud based applications, Non product software, Cybersecurity, Artificial Intelligence
Strong understanding of Quality Management Systems (QMS) and software lifecycle standards
Experience with risk based auditing and familiarity with GxP principles desirable
Experience with product submissions or regulatory audits desirable
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
Company data provided by crunchbase