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Staff Device Lifecycle Engineer
看过: 187
更新日: 25-03-2024
位置: Schaffhausen Schaffhausen SH
类别: 质量保证/质量控制
行业: Information Technology Services Financial Services Hospital & Health Care
水平: Associate
工作类型: Full-time
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工作内容
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.Are you passionate about crafting a world without disease? Do you have expertise in Health Economics and Market Access? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science.
Janssen Supply Group, L.L.C.is recruiting for a Staff Device Lifecycle Engineer, in Schaffhausen
(Permanent)
Overview
The Engineer will be accountable to work in a multi-functional setting collaborating in device development, technical transfer and manufacturing lifecycle support. The Engineer is responsible for the ongoing lifecycle engineering and technical support for the device constituent and processes of combination products in the Janssen Supply Chain network. The Engineer will transition the responsibilities from development to manufacturing and take accountability for the lifecycle of devices for design control, process, quality and cost improvements, complaint analysis, CAPA and audit support as required. They will be the key point of contact to site operations and quality leadership for their area of responsibility.The Staff Device Lifecycle Engineer will ensure that all device lifecycle activities are in compliance with all applicable procedures and to the requirements of 21 CFR Parts 3, 4,11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products, Pharmaceuticals, and Medical Devices.
The Staff Device Engineer will lead, handle and support product and process quality improvement and reliability projects for combination product operations across the globe. Responsibilities include:
- Support Lifecycle Engineering for Device manufacturing to ensure technical and quality aspects are delivered for Janssen combination products per quality systems requirements.
- Device life-cycle engineering including process engineering, product engineering and support to site or external manufacturing network as necessary.
- Viewed as an authority in aspects of the end to end medical device development, production and supply chain.
- Train and mentor resources in the supply chain to improve overall knowledge and enhance capabilities for technical support of devices and combination products.
- Lead and/or provide technical expertise to projects vital to address issues with customer satisfaction, quality, manufacturing or assembly improvements and cost reductions.
- Support manufacturing sites in solving problems and technical issues.
- Lead design change controls for devices, perform technical assessments on combination product change controls and translate requirements into device design control activities.
- Develop manufacturing operations and process for device production to ensure a robust and reliable delivery of the combination product.
- Ability to write, comprehend, analyze and/or interpret instructions, drawings/specifications, business, professional, scientific documentation, journals or SOP’s.
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最后期限: 09-05-2024
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