Quality Systems Engineer II

Role: Quality Systems Specialist responsible for managing and ensuring compliance of the company’s Quality Management System (QMS) in a medical device environment. Objectives include maintaining regulatory adherence, supporting audits, driving continuous improvement, and overseeing CAPA and change control processes. Responsibilities encompass implementing and maintaining QMS procedures, facilitating internal and external audits, conducting gap analyses to standards, managing nonconformance resolutions, analyzing KPIs, and supporting QMS software systems. Qualifications: Bachelor’s degree in a scientific or technical field or equivalent experience; 3+ years in quality assurance/engineering roles within regulated environments. Preferred certifications include ASQ CQA/CQE/LSS and AATB CTBS. Skills include experience with electronic QMS tools, strong analytical/problem-solving capabilities, effective communication, and knowledge of GMP, tissue banking regulations, and ISO standards. High-value: Focus on medical devices (vascular/tissue), compliance with GxP standards, audit and CAPA expertise, and experience with tissue recovery/auditing. Work setup details are not specified.