Waters Corporation

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Product Compliance Specialist

Product Compliance Specialist

System ID 
8359
Company Name 
Waters Division
Category 
Informatics
Job Locations 
UK-Cheshire-Wilmslow
Employment Type 
Regular Full-Time
Job Location : Country (Full Name) 
United Kingdom

More information about this job

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 recruiting a product compliance specialist to lead and facilitate product risk management activities for complex hardware-software solutions. This is a senior role within the application software group, offering a balance of strategic and hands-on responsibility working across multiple product lines developed as in-vitro diagnostic (IVD) medical devices. It will involve supporting early and late stage development programs for software products with particular focus on product risk management, usability and cyber security.

Responsibilities

  • Act as a subject matter expert (SME) for the Waters product risk management process for IVD software products, providing interpretation and guidance on industry best practice / state of art for risk management activities supporting the Product Development process.
  • Lead generation and maintenance of Risk Management Files, Usability Files and when applicable Technical Files, including co-ordinating input from other functions especially clinical SMEs and post market surveillance.
  • Provide training to personnel on product compliance regulations, best practice and application.
  • Provide leadership and direction on all product risk management activities necessary for the project teams to achieve design control deliverables, specifically deliverables related to product safety, usability and cyber security.
  • Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support design control risk management related activities and ensure consistency between projects and products.
  • Keep abreast of changes to international regulatory requirements relevant to risk management activities that may affect Waters products.
  • Work cross-functionally and cross-site to ensure activities and potential improvement work is aligned and harmonised.
  • Proactively escalate issues and risks through appropriate channels to Senior Management.

Qualifications

  • Proven experience of product risk management for IVD / medical devices utilising ISO 14971
  • Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820.
  • Extensive knowledge and use of a variety of risk management tools, usability and cyber security methodologies to drive product quality and compliance.
  • Demonstrated ability to apply risk management practices in efficient and effective ways while ensuring compliance. A solutions-based approach to compliance.
  • Excellent communication, analysis and decision-making skills.
  • Proven ability to facilitate activities, lead teams and contribute in a team environment.

The following are highly desirable:

  • Experience working within a complex hardware-software development environment (guided by EN 62304).
  • Experience working in an agile software engineering environment
  • Degree in engineering or science, or equivalent combination of qualifications and experience.