Senior Manufacturing Quality Engineer

Senior Manufacturing Quality Engineer – an innovative and rapidly expanding medical technology company is seeking a Senior Manufacturing Quality Engineer to support the development, implementation and continuous improvement of its manufacturing and supplier quality processes. This role is remote-based in Galway, with occasional travel to key manufacturing partners.

This opportunity offers the chance to work on ground-breaking medical technologies that aim to transform clinical diagnostics and patient care. The successful candidate will work closely with contract manufacturers and global suppliers, ensuring quality standards are met and continuously improved across the supply chain.

RESPONSIBILITIES: 

• Lead root cause analysis (RCA) and failure mode analysis (FMEA) to drive resolution of manufacturing issues

• Implement effective corrective and preventive actions (CAPA) and support production quality improvement initiatives

• Monitor key quality metrics and drive continuous improvement in yield, defect rate and process efficiency

• Collaborate with external manufacturing partners to validate processes and ensure alignment with internal quality systems

• Develop and manage Supplier Quality Management programs to maintain high-quality material and component supply

• Support supplier selection, performance evaluation and corrective/preventive actions

• Ensure compliance between internal QMS and those of manufacturing partners

• Support new product transfer projects and contribute to process validation and qualification activities

• Conduct internal and supplier audits in line with industry standards and regulatory requirements

• Provide cross-functional support and guidance on quality issues across departments

REQUIREMENTS: 

• 7–10 years’ experience in manufacturing or supplier quality engineering within a regulated industry (e.g. medical devices, pharma, automotive)

• Lead Auditor certification with hands-on experience conducting supplier audits

• Strong understanding of process validation, CAPA, statistical process control and quality assurance methodologies

• Experience working with contract manufacturers or outsourced production

• Strong communication and influencing skills with the ability to work across internal teams and external partners

• Effective project management skills, with the ability to manage multiple priorities

• Willingness to travel up to 25% (primarily within Ireland and Europe)