Waters Corporation

  • Principal Design Quality Engineer, Software

    Req. #
    8285
    Company Name
    Waters Division
    Category
    Quality Assurance
    Location
    US-MA-Milford
    Type
    Regular Full-Time
  • 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 over 100 countries around the world.

     

     

    Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. 

    Overview

    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 regulated environment.
    • Desired - Experience of leading quality assurance activities supporting software development in a regulated 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.

     

    Key Words

    Quality Assurance, Design Assurance, Design control, Software Quality Assurance, ISO

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