Waters Corporation

  • Principal Design Quality Engineer, Software

    System ID
    8238
    Company Name
    Waters Division
    Category
    Quality Assurance
    Job Locations
    UK-Cheshire-Wilmslow
    Employment Type
    Regular Full-Time
    Job Location : Country (Full Name)
    United Kingdom
  • Company Description

    For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in more than 100 countries around the world.

     

     

     

    Waters Wilmslow site is the largest site globally committed to the support and development of Mass Spectrometry systems. This fantastic site is designed to create and support connectivity and efficiency by enabling us to embrace more collaborative ways of working and focus more on customer needs, quality and continual improvement in the way we innovate and design our products and systems.  This site not only brings advantages that benefit our own employees, but also provides a high-tech center for customers. 

     

    A custom built Center of Excellence

    Driving innovation in the birthplace of Mass Spectrometry
    State of the art customer demonstration laboratories
    Investing in world changing research development and manufacturing
    Science in harmony with a sustainable world

    Overview

    Waters is developing solutions that make a meaningful impact on the world

     

    • Waters Helps Scientists in the Fight Against Cancer
    • Waters Helps Ensure The Quality & Safety of Food and Beverages
    • Waters Helps Drive Innovation in Chemical Materials
    • Waters Helps Scientists manufacture innovation for biodegradable plastics, safer cosmetics and latest consumer electronics
    • Waters Leads the way in helping scientists find ground-breaking treatments

    Waters Corporation is currently seeking a Principal Design Quality Engineer, Software to join our company. 

    In this role, the individual will join our Quality team in the function of Design Assurance to help contribute to the establishment, implementation and maintenance of the quality management system in support of the Software Design and Development for Product Software.  Specifically, the individual will help ensure the highest levels of software product quality and customer satisfaction while maintaining statutory and regulatory compliance for Software. 

    This is a great opportunity for an individual to help grow our business and expand our next generation products/emerging technologies. 

    Responsibilities

    • Assume a Subject Matter Expert (SME) on Product Software development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution
    • Act as Quality specialist in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
    • Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies - mentor/train personnel involved in software development in respective to “Best Practices”.
    • Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met.
    • Provide leadership and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance.
    • Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification/validation etc.) including software risk management, maintenance, configuration management and problem resolution.

    Qualifications

     

     

    • Minimum of Bachelors Degree.  Preferably within Computer Science, systems engineering or related Engineering fields of study
    • Minimum 7 years experience supporting quality assurance activities within software development. Preferably within regulated industries 
    • Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
    • Desired - Experience of leading quality assurance activities supporting software development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
    • Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment.
    • Extensive knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to drive software product quality for new product development in a ISO 9001 environment.
    • Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide “added value”.
    • Strong leadership, coaching and mentoring skills.
    • Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills.

     

     

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