Waters Corporation

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Software Design Quality Assurance Manager

Software Design Quality Assurance Manager

System ID 
7704
Company Name 
Waters Division
Category 
Quality Assurance
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 developing solutions that make a meaningful impact on the world

 

  • Waters Helps Scientists in the Fight Against Cancer
  • Waters Helps Ensure The Quality & Safety of Food and Beverages
  • Waters Helps Drive Innovation in Chemical Materials
  • Waters Helps Scientists manufacture innovation for biodegradable plastics, safer cosmetics and latest consumer electronics
  • Waters Leads the way in helping scientists find ground-breaking treatments  

As a Software Design Quality Assurance Manager within the Informatics Quality function, you will lead, shape and enable the development lifecycles and related compliance files of Application Software Products which are critical to our business needs. The product portfolio includes non-IVD, IVD class I and IVD class II products.

 

This new role will coordinate quality assurance activities related to design and development globally across facilities and align with the Waters Strategy.

 

We are looking for a self-motivated quality manager to join our truly exceptional team. 

 

Responsibilities

  • Manage the Software Design Quality team within Informatics Quality organisation, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible, providing strategic direction and leadership.
  • Act as Quality specialist in relation to Medical Device software design and development.
  • Lead continuous improvement activities with aim to increase out of box product quality and Waters customer experience, utilising internal and external customer feedback data.
  • Lead application software design and development activities ensuring conformance and up-to-date information on applicable regulatory requirements.
  • Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met.
  • Provide interpretation and guidance on quality standards, regulations and directives including industry and best practices
  • Provide coaching, training, mentoring, solution based guidance, and act as a functional expert and provide appropriate guidance to the business and sites
  • Monitor and report the effectiveness and efficiency of the Informatics and Quality activities, generate measures and metrics, trend and propose improvement actions.
  • Work cross functionally and within Waters Global Quality Assurance to ensure activities and potential improvement work is aligned and harmonized.

Qualifications

  • Degree in relevant subject area (for example BS in Computer Science, systems engineering or Engineering) or relevant experience.Proven experience in Leadership role
  • Proven knowledge of software product design and execution of processes compliant to ISO 9001, ISO 13485 and ISO 62304
  • Working knowledge of Agile software development methodology.
  • Significant experience of quality design assurance with a strong working knowledge of various Software Development Life Cycle (SDLC) models and validation testing methodologies (experience in a medical device environment would be beneficial).
  • Demonstrated capability to lead, manage and drive change through a multi-disciplinary, geographically distributed team.
  • Strong leadership, coaching and mentoring skills.
  • Desired - proven knowledge of design and execution of processes compliant to ISO 14971, ISO 62366, and 21 CFR 820
  • Exceptional interpersonal and communication skills.
  • Excellent attention to detail.
  • Ability to work on one’s own initiative.
  • Ability to travel (domestic or international).