Staff Auditor, Quality Systems- Medical Devices

The Opportunity 

We are seeking an experienced Quality Systems Auditor with expertise in medical device and software auditing to support internal audit program required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support.  

This role will support Medical Device Products. 

What You’ll Work On 

Internal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting.   

Support the development, training, and supervision of auditors to improve their ability to provide inspection readiness support.   

Lead and mentor staff, influence colleagues and peers, and continually strive to improve the audit and inspection readiness programs.  

Provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities.  

Lead the planning, development, and implementation of internal audit schedules and riskbased audit plans, specifically incorporating software lifecycle and validation requirements. 

Conduct in-depth Quality System audits across Abbott manufacturing sites. 

Perform detailed assessments of software development and validation practices, cybersecurity controls, risk management (ISO 14971), and documentation for technical completeness and compliance. 

Evaluate adherence to global regulations and standards including:  

• FDA 21 CFR Parts 11 & 820 

• ISO 13485 

Required Qualifications 

• Bachelors Degree (± 16 years), Related field OR an equivalent combination of education and work experience,  

•  Masters Degree (± 18 years) Preferred   

• Minimum 6 years, Related work experience with a strong understanding of specified functional area.  

• Solid understanding and application of business concepts, procedures and practices.  

• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.  

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  

• Has a sound knowledge of a variety of alternatives and their impact on their business unit.  

Preferred Qualifications 

Prior experience performing or leading audits focused on:  

• Medical Device Products 

• Medical Device Software 

• Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) 

• NonProduct Software (GxP tools, automated systems) 

• Artificial Intelligence 

Strong working knowledge of software and device regulations and standards:  

• IEC 62304, ISO 13485, ISO 14971 

• FDA 21 CFR Parts 11 & 820 

• EUMDR 

• GAMP 5 CSV principles 

Experience preparing for and supporting FDA or global regulatory inspections. 

Experience managing multisite or crossfunctional projects to completion. 

Excellent technical writing and communication skills, including executive-level reporting. 

Lead Auditor certification (e.g., ISO 13485 Lead Auditor) desirable. 

Ability to travel 25–50%, sometimes with short notice.