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:

• Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
• 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.
• Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures.
• Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement.
• Carry out supervisory responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, performance management, and employee development.
• Plan, assign, and direct work; evaluate performance; recognize achievements; address employee concerns.

• 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.
• Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools).
• Ability to support product development, manufacturing, and product release activities as directed by senior management.
• Excellent technical writing and verbal communication skills.