QA RA Specialist

Location: Remote in the US. Type: Full-time, permanent Visa Sponsorship: Unfortunately, we are not in the position to offer visa sponsorship for this role. About this Role  We are seeking a QA/RA Specialist, Clinical, North America to join our Diagnexia team in the US. This is a key role within the QA/RA Clinical group, responsible for ensuring that clinical laboratory operations, products and services across Diagnexia US and Diagnexia Canada meet the highest quality and regulatory standards. The successful candidate will bring combined expertise in quality assurance and regulatory affairs, acting as a single point of accountability for QA/RA matters across our North American clinical operations.  Responsibilities:  Quality Assurance Implement and maintain procedures to meet OIG, CLIA, CAP and federal and state regulations, working closely with Clinical Operations to ensure the quality and integrity of test data, laboratory and service activities at the Chicago site and across Diagnexia's North American clinical operations Own the internal Quality Audit programme, executing audits of in-house processes, systems and facilities as well as vendor and supplier audits, to ensure compliance with regulatory requirements and company standards Manage quality processes including planned deviations, non-conformances, corrective and preventive actions (CAPAs), change management and maintenance of the risk register Incident management including triage, escalation where needed, investigation and root cause analysis (eg 5 Whys) Ensure the clinical laboratory and services are inspection ready at all times, and support regulatory inspections and audits as required, including FDA, CAP and CLIA Coordinating validation activities for new/updated clinical workflows, sites and scanners, including protocol preparation, pathologist coordination, result review and compiling validation reports and supporting evidence. Provide QA input across document reviews, supplier management, information security and data privacy processes Support client audits of clinical processes and coordinate post-audit activities, working closely with client quality teams on training, audit coordination and client evaluation documents Provide routine quality metrics to management for KPI monitoring and trend analysis Support the laboratory safety programme Drive continuous improvement, collaborating with cross-functional teams to identify and resolve quality issues and implement process improvements in line with best practice, including CAP, CLIA and HIPAA Regulatory Affairs Work with Clinical and Laboratory Operations, QA/RA, Commercial, Legal and R&D teams, in collaboration with the Director of QA/RA, Clinical, to develop, maintain and implement regulatory plans, strategies and compliance plans for clinical digital pathology products and services in the US and Canada, including AI-enabled technologies Compile and review technical…