Waters Corporation

  • Senior Design Quality Assurance Engineer

    System ID
    8924
    Company Name
    Waters Division
    Category
    Quality Assurance
    Job Locations
    UK-Cheshire-Wilmslow
    Employment Type
    Regular Full-Time
    Job Location : Country (Full Name)
    United Kingdom
  • Overview

    This position will be accountable for concurrent quality engineering activities associated with new product development, risk management, conformity to applicable quality management systems and Waters requirements for instrument hardware and software. Primary responsibility will be to handle quality engineering duties in the following areas: design controls, risk management, previous product analysis, change control, post market review, quality planning, continuous improvement and establishment of appropriate requirements management and traceability.

    Responsibilities

     Role specific:

    • Participate in new product development projects by providing quality engineering support for assigned projects. Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations.
    • Key deliverables include, but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
    • Facilitating Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Risk Analysis, Risk Management Reporting and maintaining Risk Management File.
    • Monitor Issue Databases to identify product quality trends and translate this information into improved product designs. Facilitate and participate in Root Cause Analysis of identified product and process deficiencies initiating system corrective actions as required.
    • Monitor, review and update product development practices and associated documentation to ensure conformity to regulatory requirements and provide continuous improvements with the aim to increase product quality to Waters customers.

    General:

    • Fully support the Quality Policy and Business Goals by building quality in to all aspects of work and maintaining compliance to quality and regulatory requirements.
    • Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR [deviation, material faults, internal audit, external audit]
    • Responsible for maintaining the effectiveness of the Quality system at the site via adherence to applicable policies and procedures.

    Qualifications

    Education:

    A qualification in an Engineering/ Physical Science degree, HND level, proven relevant experience in an Engineering/Science related function, or significant proven experience within a regulated occupational environment.

     

    Experience:

    • Experience in the application of design controls and risk management including requirements management, design reviews, design verification, design validation, design transfer, process validation, process control plans and statistical process control.
    • Experience in product development of complex systems (mechanical, electrical, and software).
    • Working Knowledge and experience with ISO 9001.
    • Knowledge and experience with ISO 13485, 21 CFR part 820, IVDD 98/79/EC, MDD 93/42/EEC, ISO62304, IEC62366-1 and ISO14971 or equivalent is desired.
    • Qualified Lead Auditor is desired.
    • Experience in Design for Six Sigma, Manufacturability, Service, Inspection is desired.
    • Experience with Root Cause Analysis techniques e.g. 8D, 5 Whys, Cause and Effect Analysis and knowledge of continuous improvement techniques.

       

    Competencies:

    • Good technical writing and oral communication skills are required to ensure succinct report generation and effective communication.
    • Ability to constructively challenge designs and engage in transparent conversations.
    • Strong analytical skills with the ability to identify, analyze, and solve problems with minimal direction and make decisions with confidence.
    • Strong project management skills, proven ability to facilitate activities, balance and prioritize multiple ongoing projects/tasks, lead teams, contribute effectively in a team environment and build strong working relationships.
    • Must be able to work independently and communicate with all levels of the organisation.
    • Foster an environment that values diversity and inclusion.
    • Computer literate, preferably with knowledge of software packages such as Word, Excel, and PowerPoint.

     

    In addition to salary, we have a flexible approach to work, 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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed