Senior Quality Engineer with ith ISO 13485 and FDA QSR expertise required by leading Galway Medical Devices company to support manufacturing processes and drive continuous improvements. This role offers the opportunity to work in a collaborative, high-performing environment where quality is at the core of innovation and patient safety.
Key Responsibilities
Manufacturing & Process Quality Support – Analyze process and manufacturing data, identify trends, and assist in yield reporting.
Root Cause Analysis & CAPA Management – Investigate quality issues, manage non-conformances (NCs) and CAPAs, ensuring timely resolution.
Statistical Process Control (SPC) & Risk Management – Implement quality control tools (SPC, Cpk, Ppk) and drive risk management (Process FMECA).
Materials & Compliance Oversight – Establish inspection plans, frequencies, and test methods for incoming materials and ensure GMP compliance.
Quality System Leadership – Drive continuous improvement initiatives in compliance with ISO and FDA regulations.
Training & Team Development – Train, develop, and manage resources within the Quality Engineering team, ensuring alignment with company goals.
Stakeholder Engagement – Collaborate with suppliers, customers, and regulatory bodies to maintain the highest quality standards.
What You’ll Need
Degree in Engineering, Science, or related field.
8+ years of Quality Engineering experience in the medical device industry.
Strong expertise in ISO 13485 & FDA QSR compliance.
Proven leadership experience, with the ability to manage and develop teams.
Hands-on experience with CAPA, NCs, SPC, Process Validation & Risk Management.
Ability to work autonomously and as part of a high-functioning team.
Strong technical writing skills – capable of producing clear and concise reports, protocols, and regulatory documentation.
Excellent organizational skills, with a keen eye for detail and ability to meet strict deadlines.
Strong interpersonal & communication skills, with the ability to engage effectively at all levels of the company and with external stakeholders.
