Senior Compliance Auditor I

Abbott

1d • Onsite

About The Position

Abbott is a global healthcare leader with 115,000 colleagues serving people in over 160 countries, offering life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. Working at Abbott provides opportunities for career development, personal growth, and a full life, with access to various benefits. This Senior Compliance Auditor position is based at Abbott Park, Illinois, or another applicable Abbott location. The role is part of the Abbott Quality and Regulatory (AQR) Global compliance audit function, a corporate program that conducts audits of Quality Systems across all Abbott's manufacturing sites. This position is critical for ensuring executive management is aware of compliance business risks and regulatory requirements, as product quality and regulatory problems can significantly impact consumer health, safety, and Abbott's business performance. The ideal candidate is an experienced Senior Compliance Auditor with expertise in auditing medical devices and in vitro diagnostics, including design and development controls, to ensure patient safety and compliance with regulatory requirements, harmonized standards, and internal QMS procedures. The role involves leading risk-based audits across the full product lifecycle, focusing on quality system effectiveness, risk management, and adherence to global standards like ISO 13485, EU MDR/IVDR, and FDA Quality System Regulation (21 CFR Part 820). As a Senior Compliance Auditor, you will lead Quality System audits and assessments, participate in cross-divisional activities to integrate compliance information and regulatory trends, and proactively identify and integrate regulatory, compliance, and quality issues into audits. This role requires highly effective communication and decision-making skills with all levels of management and other departments, and the ability to work independently, exercising judgment in complex situations based on up-to-date regulatory and technical knowledge.

Requirements

• Four-year degree in a scientific, technical or compliance discipline or equivalent experience.
• In-depth knowledge of global standards and regulations including ISO 13485, ISO 14971, FDA QMSR, country specific requirements including UK, MDSAP, Health Canada, Australian TGA and China, and Japan PMDA.
• Strong analytical and problem-solving skills with attention to detail.
• Highly 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.

Nice To Haves

• Lead auditor certificate for Quality System audits.
• Certifications such as ISO Lead Auditor.
• 7+ years in the medical device industry.
• Proven history working on risk-based design including: Design planning and governance, Integration of risk management throughout the design and product lifecycle, Traceability across: User needs, Design inputs, Design outputs, Verification & validation, Design reviews (independence, adequacy, escalation), Design transfer and production readiness, Design changes, impact assessments, and re‑validation triggers, Assessment of residual risk and risk-benefit justification.
• Strong understanding of Quality Management System (QMS) standards.
• Experience with risk-based auditing and familiarity with GxP principles.
• Experience with product submissions or regulatory audits.

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 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.
• 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 regulatory compliance.
• Review 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 education on compliance and quality topics that are key to Abbott businesses.
• Develop risk-based audit program including development of Abbott wide auditor training and competency assessments.
• Analyze compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers.
• Promote 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.

Benefits

• 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.
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees