Quality Engineering Manager

Role overview

A medical device manufacturer has opened a new hub in Galway and is hiring a Quality Manager to lead quality assurance activities across the site. The business works on catheters, medical balloons, EM-micro sensors, engineered shafts, and complete device assemblies for a broad range of interventional therapies.

Compensation and benefits

The package includes a strong salary, bonus opportunity, pension, and healthcare cover.

Key responsibilities

• Act as the appointed management representative for the site Quality Management System.
• Make sure QMS procedures and records are properly created, rolled out, and kept up to date in line with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Track QMS performance and highlight areas where processes can be improved.
• Build awareness of regulatory and customer expectations throughout the business and support ongoing compliance.
• Be the main point of contact for customers and certification bodies during external audits.
• Lead and guide all quality assurance matters, including quality systems, compliance, and material decisions/disposition.
• Ensure management review meetings are run in line with the required regulatory standards.
• Maintain control of documents and records covering products, manufacturing processes, and the QMS.

Candidate profile

• Applicants should bring 5 to 10 years of progressive experience in quality assurance and quality control within medical device manufacturing or a similar regulated environment.
• Strong people-management and leadership capability is essential.
• A thorough understanding of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives is required.

Application note

This opportunity is based in Galway. Interested candidates can apply or reach out using the contact details provided in the source listing.