EDUCATION/WORK EXPERIENCE REQUIREMENTS:

• 2-4 years of experience in Quality Engineering or equivalent industry disciplines
• Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
• Degree in Engineering/Science Discipline or related study

RESPONSIBILITIES:

• Participate (by reviewing and evaluating impact) in the disposition of non-conforming material decision-making process.
• Co-ordinate the Ballina Continence QMS processes e.g. customer complaints system, CAPA system and internal audits.
• Develop Quality Plans and work instructions, documenting procedures
• Support strategic projects aligned with Plant QA, Global Supplier Quality, Plant Operations and Global Engineering
• Conduct defect awareness training sessions
• Participate in internal/external audits

ESSENTIAL FUNCTIONS OF THE ROLE:

• Knowledge and application of basic statistics
• Good Communication skills, both written and oral
• Strong technical writing skills
• Ability to train/facilitate
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferred
• Knowledge of Lean and Six Sigma principles
• Ability to achieve results through working with cross functional teams
• Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel).