Cache of job #13866832

Job Title

Senior Quality Engineer

Employer

Bd Medical

Location

Limerick

Description

The Sr. Quality Engineer is 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. The incumbent will be capable of self- direction and project management to ensure successful outcomes. You will provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards. You will support new product development and existing product sustaining activities to ensure work follows proper design. control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development. teams and identifying Quality needs, product improvements and customer requirements. You will ensure adequate design control documentation and records are maintained to support life cycle of design history. You will 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. You will be 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. You will ensure the design is appropriately specified and established before transferring into manufacturing to avoid increased risk. You will review and authorize Quality approval for new product and/or device design specifications including product. performance specifications, test methods, acceptance criteria, and release. You will support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports. You will review and assess work performed by R&D and other BD 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. You will work with the Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and. Process Validation. You will lead or participate in Risk Management activities appropriate to the initiative or situation. You will 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. You will initiate Corrective and Preventative Action plans and perform efficacy follow up. You will conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and. regulatory requirements. You will participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs. and established Quality Systems. You will support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed. You will support activities relating to Field Corrective Actions, when needed. You will provide guidance quality and training to other quality engineer to help increase knowledge of regulations and. standards for Devices and Combination Products. Qualifications: You will have a minimum of 5 years of general process / manufacturing experience. You will have a minimum of 5 years of experience working in a FDA or ISO regulated environment. You will have aminimum of a bachelor’s degree is required. Assets: You will be a BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science. Certified Quality Engineering (CQE) preferred. You will have a 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. You will have 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. About Us. BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. This job originally appeared on RecruitIreland.com.

Date Added

2229 days ago

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