Quality Engineer – Medical Device Manufacturing (12 month FTC initially)
Location: Ballina, County Mayo, Ireland
An exciting opportunity has arisen for a Quality Engineer to join a leading medical device manufacturing company based in Ballina, County Mayo. This is a great role for an individual with a strong background in quality assurance and medical device regulations, looking to contribute to a company that values innovation and continuous improvement.
Key Responsibilities:
* Non-Conforming Material Management: Participate in evaluating non-conforming materials and support the decision-making process to determine corrective actions.
* Quality Management System (QMS) Coordination: Oversee key QMS processes including customer complaints, CAPA (Corrective and Preventive Action) system, and internal audits to ensure compliance with company and regulatory standards.
* Documentation Development: Create and maintain quality plans, work instructions, and procedural documentation to support operations and ensure quality compliance.
* Strategic Project Support: Collaborate with cross-functional teams across Plant QA, Global Supplier Quality, Global Engineering, and Operations to support strategic projects and drive continuous improvement.
* Defect Awareness Training: Lead training sessions to promote awareness of quality standards and foster a culture of quality within the organisation.
* Internal/External Audits: Actively participate in internal and external audits, ensuring compliance with quality standards and regulations.
Key Skills & Requirements:
* Experience: 2-4 years’ experience in Quality Engineering or a related field, preferably within medical device manufacturing.
* Regulatory Knowledge: Familiarity with FDA (21 CFR 820) and ISO 13485 standards is highly desirable.
* Statistical & Analytical Skills: Ability to apply basic statistical methods to assess and improve product quality.
* Strong Communication Skills: Excellent verbal and written communication skills to effectively interact with teams and stakeholders.
* Technical Writing: Proficient in creating clear, concise technical documentation.
* Lean & Six Sigma Knowledge: Understanding of Lean and Six Sigma principles is advantageous.
* Computer Skills: Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Access).
Education:
A degree in an Engineering or Science discipline is preferred.
Why County Mayo?
County Mayo offers a high quality of life, combining beautiful natural landscapes, rich cultural heritage, and a friendly community. Enjoy outdoor activities, a thriving local economy, and a great work-life balance in one of Ireland's most scenic locations.
If you are a driven Quality Engineer with a passion for medical devices and quality improvement, apply today to join an innovative team that is committed to excellence.
#J-18808-Ljbffr