Quality Engineering Team Leader
QualityEngineering Team Leader. Limerick. You will be accountable for quality support for devices, products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. You will be capable of self- direction and project management to ensure successful outcomes You will manage a team of 3. This role reports into the US. Responsibilities: Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards. Support new product development and existing product sustaining activities to ensure work follows proper design. control. Ensure controls meet company and FDA regulatory requirements by actively participating on product development. teams and identifying Quality needs, product improvements and customer requirements. Ensures adequate design control documentation and records are maintained to support life cycle of design history. Provide support for each aspect of design control and ensure tasks are completed adequately to include project. planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and. design history files and other activities as needed. Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an. acceptable quality level during manufacturing with properly established product specifications. Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk. Review and authorize Quality approval for new product and/or device design specifications including product. performance specifications, test methods, acceptance criteria, and release. Support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports. Review and assess work performed by R&D and other business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues. Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and. Process Validation. Lead or participate in Risk Management activities appropriate to the initiative or situation. Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer. input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with. Manufacturing, Service, Engineering, Regulatory and Biostatics. Initiate Corrective and Preventative Action plans and perform efficacy follow up. Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet company and. regulatory requirements. Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs. and established Quality Systems. Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed. Support activities relating to Field Corrective Actions, when needed. Provide guidance quality and training to other quality engineer to help increase knowledge of regulations and. standards for Devices and Combination Products. Qualifications: A Minimum of 10yrs PQE - with 5 years of general process / manufacturing and 5 years of working in a FDA or ISO regulated environment. Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science. Certified Quality Engineering (CQE) preferred. Assets: Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools. Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected. This job originally appeared on RecruitIreland.com.
340 days ago