Waters Corporation

  • Sr. Design Quality Engineer, Chemistry

    Req. #
    8133
    Company Name
    Waters Division
    Category
    Quality Assurance
    Location
    US-MA-Milford
    Type
    Regular Full-Time
  • Overview

    This position will be responsible for concurrent quality engineering activities associated with chemistry product development and risk management on columns, kits and column products. Primary responsibility will be to handle quality engineering duties throughout the development life cycle in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements and traceability. The candidate will play an active role in the chemistry development processes to ensure products meet quality standards consistent with company policies

    Responsibilities

    This individual will be responsible for providing quality leadership, guidance and support in quality system methodologies for product development. This candidate will work directly with product development teams in support of the development of products within the chemistry business unit. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.

     

    In this position, the candidate will be responsible for:

    • Participating or leading in design and development planning; quality planning; supporting development of design requirements specification; Design History File management, design transfer activities, change management and design reviews;
    • Developing risk management documentation;
    • Supporting development of design verification and design validation documentation;
    • Supporting test method development and validations;
    • Ensures company policies, procedures, practices and facilities are in compliance with all applicable company policies and procedures;
    • Lead/support internal investigations, implementing corrective and preventive actions;
    • Serving as a quality representative on one or more project teams engaged in product development activities;
    • Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971, MDD 93/42/EEC, and FDA Software Guidance documents.

    Qualifications

     

    • Bachelors Degree (B.S.) in chemistry, biology or related science/technical field.
    • Minimum of four (4) years related experience.
    • Good understanding of chromatography and column products and their applications, with a strong working knowledge of development life cycle models.
    • Broad experience in the application of design controls and risk management in an IVD or Device industry.
    • Experience in the application of production and process controls including process validation, process control plans and statistical process control.
    • Good understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820.
    • Strong interpersonal and communication skills with the ability to work effectively in a team-oriented cross-functional environment and build strong working relationships and cross functional partnerships.
    • Ability to constructively challenge concerns and engage in transparent conversations.
    • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.  

    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

    ISO 13485, ISO 14971, Chemistry, LCMS, Chromatography, Biology, Mass Spectrometry, Biomedical Engineering, Design Controls, Risk Management, Product Development, Quality Assurance, QA

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