Waters Corporation

  • Principal Design Quality Engineer, Software

    Req. #
    8285
    Company Name
    Waters Division
    Category
    Quality Assurance
    Location
    US-MA-Milford
    Type
    Regular Full-Time
  • 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 
    • 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 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 (e.g. ISO 13485, ISO 62304, 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 and root cause analysis methods, design and process control activities, verification and validation testing methodologies to drive software product quality for new product development in an 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 coaching and mentoring skills, with exceptional interpersonal and communication abilities.
    • Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills.

    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 nearly 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.

     

     

    Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status. 

     

    Key Words

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

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