Senior Specialist Quality Assurance (Supplier Quality)

Senior Specialist Quality Assurance (Supplier Quality) Position overview: The Senior Specialist QA will support the selection, approval, and maintenance of approved suppliers within the Abbott Molecular Diagnostics Division, DesPlaines, IL. Responsibilities Lead Supplier Quality Management process improvements including supplier change notifications, CAPA activities, new product introduction support, quality audits, complaint investigations, and supplier metrics/monitoring. Perform supplier quality system assessments and monitor supplier performance, driving corrective actions and improvement activities. Analyze complex problems, assess impacts and probabilities, and develop solutions that align with business needs. Ensure compliance with applicable regulations and collaborate with other Abbott divisions or Division sites. Travel up to 25% domestically to support supplier management goals. Complete documentation in a timely manner and in accordance with business standards. Understand and comply with EHS policies, procedures, and guidelines. Contribute to functional performance and meet cross‑functional standards and expectations. Make timely and effective decisions, elevate high‑risk issues, and recommend appropriate actions. Required Qualifications Bachelor’s degree in science, engineering, or a closely related discipline (or equivalent education and experience). Minimum 5years relevant experience in quality, compliance, or engineering within a regulated environment (medical devices, diagnostics, or pharmaceuticals). Knowledge of US and non‑US Quality System Requirements, ISO13485, and regulatory requirements for medical devices. Experience with audits, inspections, and CAPA processes. Strong working knowledge of quality management techniques and quality engineering principles. Proficiency in statistical analysis and problem‑solving skills. Experience using databases and computer software. Strong organizational and project management skills. Ability to influence without direct authority. Certified Lead Auditor training. Preferred Qualifications Master’s degree. Previous audit and inspection experience in regulated environments. Benefits & Other Information Base pay range: $78,000.00 – $156,000.00 (may vary by location). Travel up to 25% domestically. Abbott is an Equal Opportunity Employer, committed to employee diversity. EEO is the Law (English and Spanish versions available). #J-18808-Ljbffr