Quality Engineer

Independent Solutions

Limerick

Quality Engineer. Provides leadership and support to Water Room and Formulations process, andensures good Quality Engineering practices are in use. Drives continuousimprovement through data driven approaches and monitoring of quality systems. Job Responsibilities. Provides complex product team support for quality system design and audit,compliance assessment, and for support of steady state manufacturing processes. Utilizes multifaceted industry and process excellence standards on an expertlevel in daily quality operations, including good manufacturing practices(GMP), equipment engineering system (EES), and international organization forstandardization (ISO. Addresses and corrects product and process complaints. Ensures comprehensive measurement systems to monitor effectiveness of qualityand reliability systems to identify, bracket, correct and prevent defects,presenting reports to management. Responsible for supporting the activities of Operations/Engineering/informationmanagement in building quality into our products and assuring compliance to thepertinent regulations while at the same time attaining operationaleffectiveness. Leads and executes upgrades to Quality System. Support QA programs in assuring compliance to the pertinent regulation. Identify and lead cost and technical improvements under the departments’continuous improvement program. Provide key inputs and leadership into transformational process developments. Project Management - provide timely and accurate reporting on projectactivities. New Product Introductions & Product Transfers. Lead or actively participate in cross-functional teams to ensure New ProductIntroduction/Research and Development projects are completed in a timely andefficient manner. Actively interfacing with cross-functional team members, always practicing goodteam work in support of day to day operating requirements. Demonstrate strong leadership and a clear identifiable work ethos within theteam. Develop and maintain a Credo & Behavioural Standards based culture withinthe group. Ensure effective closure on Quality System documents (Audit Actions, NCR’s,CAPA’s, Maps, etc. Ensure all process developments, NPI etc are managed in accordance with theQuality management system. Implementation of safety/environmental requirements on purchase of all newequipment. Work with team leader to develop and implement strategic engineering Goals& Objectives. Support the implementation of all engineering and plant strategic initiatives. All employees are responsible for minimising both the Environmental and Health& Safety effects of the work that they perform. Maintains and develops risk management lifecycle. Ensuring continuous improvement and understanding of measurement systems usedon-site , driving down variance in test methodology. Develops site knowledge on manufacturing process knowledge, and monitors inputsand outputs to the processes , and implements and drives corrective actions. Education andExperience Required for Role Essential: Degree Qualified with 3-5 yearsrelevant experience in Medical Devices/Pharmaceutical Industry Ability to workon own initiative Flexible work ethic Attention to detail CAPA and RCI experienceExcellent IT skill eg , experience in minitab , excel reports Desirable Riskmanagement experience Automated process controls experience Good presentationskills Responsibilities and accountabilities will vary for all positions andthe scope of individual roles may not be limited to the contents of thisposition description. QUMAS procedures will define responsibilities from timeto time and each manager is responsible for complying with these processes,which supplant any responsibility outlined within. As such, adherence tocompany procedures is also a responsibility of this role. This job originally appeared on RecruitIreland.com.

2136 days ago