Role: Senior Quality Engineer (Operations) Location: Neurent Medical Ltd., Galway Department: Quality Assurance Reporting: Quality Manager DUTIES AND RESPONSIBILITIES: Support and mentor Quality engineers and technicians. Assign tasks, coordinate and provide instruction and feedback as required. Champion continuous improvement through CAPA system, analyzing key performance indicators etc. Lead quality-focused projects ensuring timely completion of project milestones. Ensure GMP standards and compliance in the assigned area. Work collaboratively with Operations, Supply Chain and other business functions to ensure quality performance of product and processes. Participate / lead Risk Analysis initiatives e.g. FMEA. Review/Approve Validation protocols, reports (IQ, OQ, PQ) and engineering changes. Develop and maintain documentation in compliance with FDA& ISO requirements. Collate, trend and report on Quality KPI’s. Perform internal and external audits to ISO and FDA requirements. Support Notified Body / Regulatory Agency / Customer Audits. Support the environmental monitoring process and activities associated with sterilization. Actively participate in management review, compliance meetings and other key review meetings. Act as the QA representative on Design Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation. Supplier Management & Qualification: Maintain supplier records and systems, manage Approved Supplier List (ASL) activities, qualify new suppliers through agreements, assessments, audits, and onboarding to the Approved Vendor List (AVL). Coordinate supplier change requests and qualification plans, monitor supplier performance through scorecards and reviews, and conduct audits to drive corrective actions and ensure compliance. Undertake additional tasks as directed by the Quality Manager in line with company goals, and act as delegate for Quality Manager when required. EDUCATION/EXPERIENCE: Level 8 Degree in Science / Engineering, Quality Engineering or similar qualification. Minimum 5 years’ experience in a relevant role in the medical device industry. Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage. Experience in root cause analytical and problem-solving skills. Experience of FDA and ISO Quality systems (e.g. ISO13485, FDA QSR 21CFR Part 820) for medical device companies desirable. Significant test method and process validation experience. Demonstrated excellent organizational skills and ability to work on own initiative essential. Excellent written and verbal communication skills. #J-18808-Ljbffr
Reporting: Operations & Manufacturing Engineering Manager Description: Neurent Medical is actively seeking a Senior Manufacturing Engineer to join our expanding engineering team. In this role, you will be integral to optimizing, supporting, and advancing our manufacturing processes through the application of technical expertise and Lean principles. This is an exciting opportunity to make a significant impact in the development and production of innovative devices within the rapidly evolving field of minimally invasive ENT therapeutics. Duties & Responsibilities The successful candidate will have responsibility for, but is not limited to, the following skillsets: Collaborating with other engineers and production teams to develop and improve manufacturing processes. Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives. Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using Lean methodologies as this is an integral part of the role. Apply structured problem-solving techniques to process, material or equipment issues while offering manufacturing or quality ideas from experience. Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements. Perform process analysis and identify areas for improvement, recommending and implementing solutions to enhance productivity and efficiency. Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations). Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes. Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability. Skills & Experience Required: Degree level 8 in Engineering or related discipline with 5 years + relevant experience – additional relevant qualifications may be advantageous. Green Belt certification is a distinct advantage. Experienced with medical device process and manufacturing development and project/program management, risk analysis and problem-solving skills. Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes. Dynamic team player and can work effectively and proactively on cross-functional teams. Excellent organizational and interpersonal skills, proactive and likes to take ownership of tasks/projects. Good understanding of lean principles and methodology. (e.g. DMAIC, Kaizen, Value Stream Mapping) Excellent understanding of ISO 13485 and FDA processes. Experience with statistical techniques (DOE, Six Sigma). Proficiency with engineering software (e.g., AutoCAD, SolidWorks) #J-18808-Ljbffr
