Sr QA Technician

We are seeking a Sr QA Technician (Batch Release) to join our team in Birmingham. In this role, you will be responsible for performing batch release activities, ensuring regulatory compliance, verifying Device History Records (DHRs), and maintaining high quality standards. You will serve as a key point of contact for GXP documentation and support ongoing quality management initiatives.

• Batch Release & DHR Review: Review Device History Records (DHRs) following ALCOA+ principles to verify compliance with Device Master Records (DMRs), manufacturing procedures, and ERP information. Ensure Quality Events, Non-Conformance Reports (NCRs), and CAPAs are resolved prior to product batch release.

• Quality & Compliance: Maintain procedural and regulatory compliance (GxP, GMP, GDP, MDSAP, IVDR).

• Process Improvement: Participate in continuous improvement projects, QA standardization activities, and batch review/release documentation revisions.

• Collaboration & Communication: Work closely with cross-functional teams, participate in training initiatives, and present quality-related information.

• KPI & Metrics Tracking: Collate and communicate key performance indicators (KPIs) to monitor operational quality and analyze trend...