Senior Manufacturing QA Engineer - Medical Devices Location: Galway / Hybrid | Type: Permanent | Sector: Medical Devices | Salary: Competitive An innovative and fast-scaling medical device company is seeking a Senior Manufacturing QA Engineer to support commercial manufacturing of a cutting-edge connected health solution for chronic wound care. This role is ideal for a quality professional with experience in manufacturing, supplier oversight, and regulatory compliance. You'll work across internal operations and contract manufacturing to ensure product quality, compliance with ISO 13485 / FDA 21 CFR 820, and readiness for regulatory inspections. Key Responsibilities: Oversee quality for electronics/system-level manufacturing with CMs Lead investigations and CAPA for non-conformances Support IQ/OQ/PQ validations and documentation reviews Monitor supplier quality and contribute to audit preparedness Collaborate on regulatory submissions and inspection readiness Requirements: Degree in Engineering, Quality, or a related discipline 3-7 years in QA or manufacturing quality within a regulated industry Strong knowledge of ISO 13485, FDA QSR, and process validation Experience supporting regulatory audits or working with Regulatory Affairs teams Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications For more info, contact Seamus at Reperio or apply through the link Reperio Human Capital acts as an Employment Agency and an Employment Business. Skills: QA QMS RA Medical Devices Galway