Quality Engineer II About Your New Employer Our client is a renowned leader in the medical device industry, known for its innovative solutions and commitment to improving patient care. Join a team that works with the latest technologies and methodologies in the field. Our client offers numerous opportunities for professional development and career advancement. About Your New Job Drive and Implement Process Improvements:Ensure predictable processes across all product lines, focusing on risk reduction, yield improvements, customer complaint reduction, error proofing, cost reduction initiatives, and process automation activities. Provide QA Support:Offer effective and responsive QA support to Operations to meet quality, cost, and output objectives. Ensure Process Variables:Define and ensure all process variables and their interactions are adequately addressed, including failure modes (e.g., DOE studies, FMEAs). Quality System Improvements:Drive and implement plant-wide quality system improvements. Regulatory Compliance:Ensure compliance with GMPs and medical device regulatory agencies (e.g., FDA, TUV). Statistical Techniques:Implement appropriate statistical techniques to monitor process performance (e.g., SPC, CpK analysis, sampling techniques). Change Requests and Customer Complaints:Approve change requests for product, process, and quality system changes. Analyse returns, approve analysis reports, and analyse complaint trends. Validation and Documentation:Define validation requirements, prepare and approve Master Validation Plans, protocols, and reports. Compile required regulatory documentation (e.g., Technical files, Design Dossiers). Lean Manufacturing:Support the implementation of Lean Manufacturing across the site. Product and Process Transfer:Transfer and implement products and processes from development or other manufacturing facilities. What Skills You Need Educational Background:Minimum of a Bachelor of Science Degree in Engineering/Technology. Experience:3/4 years experience in a manufacturing environment or equivalent, with direct experience in a QA environment (preferably GMP regulated). Industry Knowledge:Experience in the medical device industry is an advantage. Whats on Offer Competitive Salary: €50,000 to €57,000 DOE plus Bonus Professional Development:Opportunities for training and career growth. Innovative Environment:Work in a dynamic and innovative environment with cutting-edge technology. Whats Next Apply now by clicking the Apply Now\" button or call me on or email. If the job isnt quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available. Skills: \"Risk Reduction\" \"Regulatory Compliance\" \"Validation\" Benefits: Paid Holidays Canteen Parking VHI Pension Negotiable Bonus