Our client a major multinational based in Galway city are looking to hire a Quality Operations Engineering Manager to support operations as they continue to expand. This is an onsite role. The Role: Reporting to the site GM, your role as the operations quality manager is to manage and provide direct and indirect supervision to skilled and intermediate-level professional employees performing diverse roles within the quality function or unit. You will be required to provide direction, coordination, and the tools needed to achieve and maintain the site Quality Management System and enable the achievement of quality objectives. Responsibilities: Supports generation of performance metrics for products and processes of moderate complexity, and drives the team to achieve Quality Goals set by management (i.e.: DPQL, Total Quality at Celestica ( )), following industry standards such as ISO, IPC, AS, TL Leads Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex. Directs and influences the preparation of documentation to support high quality regulatory submission dossiers. Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed. Acts as company representative, developing and maintaining positive relationships with the device owners through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Mentors and trains personnel in the practices of Quality management and Quality improvement (succession development) Resolves customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely. Provides leadership and support in a variety of areas such as, analysis of nonconforming materials and customer return material authorizations. (RMA's), supporting customer and 3rd party audits, and the administration of Quality management (Documentation, Change Control, Corrective & Preventive Actions and Calibration) Supports new customer qualification and New product introduction with supplier assessments, First Article Inspections and oversee generation of product documentation for products / programs of moderate risk. Requirements: Minimum of 7-10 years experience in a Quality role. 2 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required. Working knowledge of FDA and international regulations Experience working directly with FDA, notified bodies and/or international health authorities is desired. Degree qualifications (NQF L8 or L9) minimum in a related field or consideration of an equivalent combination of education and experience In depth knowledge of quality metrics, ISO standards and processes. Knowledge of Lean and Six Sigma Manufacturing processes and controls including: Statistical Process Control (SPC), 5S and Value Stream Mapping (VSM) Strong knowledge of Quality Management tools including: Failure Mode and Effect Analysis (FMEA) and development of Quality Control Plans Ability to coordinate a wide variety of resources to meet production quality and quantity metrics. Ability to effectively communicate with a wide variety of internal and external customers. Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment. Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint. Excellent knowledge of the manufacturing processes For more information and a confidential discussion on the role please contactMichelle Mc Inerney. Skills: Quality Operations Manager
