Assess regulatory risk and compliance impact when new testing scopes or upgrades are introduced in embedded labs. * Ensure data integrity of laboratory records, including software validation and IT infrastructure qualification. * Typically 6+ years of progressive Quality Assurance / Quality Compliance experience in a laboratory, life-science, or testing environment (medical device, pharma, sterilization, microbiology), including demonstrated leadership across multiple sites and/or within a matrix environment. * Strong working knowledge of global accreditation and regulatory standards applicable to testing laboratories (e.g., ISO/IEC 17025, GLP, and applicable national accreditation schemes).
mehr