Quality Engineering Manager

Job title: Quality Manager

Location: Galway

Benefits: Top salary, Bonus, pension, healthcare

Company:

My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies.

Responsibilities:

• Act as the Management Representative for the Quality Management System (QMS).
• Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for continuous improvement.
• Promote awareness of regulatory and customer requirements across the organization and ensure compliance.
• Serve as the primary liaison with customers and certification bodies for external audits.
• Provide leadership and direction on all QA-related matters, including quality systems, compliance, and material disposition.
• Ensure management review meetings are conducted in accordance with regulatory requirements.
• Oversee control of documents and records related to products, manufacturing processes, and the QMS.

Requirements: Education/Experience and Qualifications:

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems.
• Strong management and leadership skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.

Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie