Teams at Medline Industries

Lead end-to-end delivery of healthcare regulatory and legal initiatives. Scope, plan, execute, and govern cross-functional projects; partner with regulatory counsel and stakeholders; implement scalable tracking, reporting, and process adoption; manage metrics, timelines, risks, and communications to leadership.

Lead post-market quality activities for medical device products: develop process control and validation methods, design experiments using SPC, perform product testing and analysis, manage supplier quality and CAPA/SCAR, maintain DMRs/design control and regulatory files (including 510(k)/CE), coordinate labs, ensure compliance with global regulations, train staff, and act as quality lead as needed.

Lead quality engineering for diagnostic medical products: develop/validate process controls, run SPC and experiments, manage supplier quality and CAPA/SCAR, create DMRs/design control files/CE technical files and support 510(k) activities, investigate nonconformances, ensure regulatory compliance, and train staff.