Waters Corporation

  • Systems Assurance Engineer

    System ID
    9166
    Company Name
    Waters Division
    Category
    Informatics
    Job Locations
    UK-Cheshire-Wilmslow
    Employment Type
    Regular Full-Time
    Job Location : Country (Full Name)
    United Kingdom
  • Overview

    In Waters, the Informatics group produce software that is used by people worldwide for specialist measurement and scientific analysis. We are currently seeking an Systems Assurance Engineer / Product Compliance Specialist to lead and facilitate product risk management activities for complex hardware-software solutions. We work in a collaborative, agile environment, where team members are empowered to innovate and continually improve. We believe strongly in the value of personal development, and provide support and dedicated time for our people to pursue this.

    This is a senior role within the application software group, offering a balance of strategic and hands-on responsibility working across multiple product lines developed as in-vitro diagnostic (IVD) medical devices. It will involve supporting early and late stage development programs for software products with particular focus on product risk management, usability and cyber security.

    Responsibilities

    • Act as a subject matter expert (SME) for the Waters product risk management process for IVD software products, providing interpretation and guidance on industry best practice / state of art for risk management activities supporting the Product Development process.
    • Lead generation and maintenance of Risk Management Files, Usability Files and when applicable Technical Files, including co-ordinating input from other functions especially clinical SMEs and post market surveillance.
    • Provide training to personnel on product compliance regulations, best practice and application.
    • Provide leadership and direction on all product risk management activities necessary for the project teams to achieve design control deliverables, specifically deliverables related to product safety, usability and cyber security.
    • Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support design control risk management related activities and ensure consistency between projects and products.
    • Keep abreast of changes to international regulatory requirements relevant to risk management activities that may affect Waters products.
    • Work cross-functionally and cross-site to ensure activities and potential improvement work is aligned and harmonised.
    • Proactively escalate issues and risks through appropriate channels to Senior Management.

    Qualifications

    • Previous experience of working in a quality system regulated environment. This may be to 13485 and/or 21 CFR 820, or equivalent from in non-medical / IVD environment.
    • Extensive knowledge and use of a variety of risk management tools, usability and cyber security methodologies to drive product quality and compliance.
    • Demonstrated ability to apply risk management practices in efficient and effective ways while ensuring compliance. A solutions-based approach to compliance.
    • Excellent communication, analysis and decision-making skills.
    • Proven ability to facilitate activities, lead teams and contribute in a team environment.

    The following are desirable, however training will be provided for the right candidate.:

    • Proven experience of product risk management for IVD / medical devices utilising 14971
    • Experience working within a complex hardware-software development environment (guided by 62304).
    • Experience working in an agile software engineering environment
    • Degree in engineering or science, or equivalent combination of qualifications and experience.

    In addition to salary, we work flexibly, and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.

    Company Description

    Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.


    Waters Corporation's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.


    Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

     

     

     

    Waters Wilmslow:

    People create the Waters difference. By engaging with our talented and diverse workforce we continuously evolve, develop and enhance our products. Being the world’s leading speciality measurement company, we believe in delivering innovative technology and system solutions to our valued customers to enable their success.  At Wilmslow, our focus is on the development and delivery of mass spectrometry systems and software in a collaborative and dynamic team environment. 

     

    Our mass spectrometers deliver benefit to customers in many industries and make a meaningful impact to our lives through examples such as

    • Neo-natal screening to keep babies healthy
    • Ensuring consistent, reliable safety in our global food and water supply
    • Developing new medicinal therapies to advance human health
    • Ensuring participants in the world’s sporting events compete fairly

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