Waters Corporation

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Manager, Design Quality Assurance

Manager, Design Quality Assurance

System ID 
7602
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

The position will lead the Wilmslow Design Quality Assurance Team to ensure the successful development and launch of new products, therapies and applications that are at the highest levels of product quality, operational excellence and customer satisfaction while maintaining compliance with applicable business, functional and global regulatory requirements.

Responsibilities

 

Role Specific

  1. Lead the Wilmslow Design Quality Assurance department, providing strategic direction and leadership, ensuring that Company and departmental objectives are met, effectiveness of the QMS is maintained and regulatory/ISO compliance is maintained
  2. Support the Global Products, Portfolio and Projects teams in the effective and efficient development of instrument and software products to ensure that user/customer needs are met and that high levels of satisfaction are achieved and maintained.
  3. Participate in and approve MS/ICS product development phase reviews and product releases.
  4. Communicate and collaborate with other members of the local Quality team on issues, ensuring that issues impacting successful phase reviews and release are identified and highlighted with the appropriate individuals or teams.
  5. Act as authorised representative for Waters Corporation with MHRA [Medicines and Healthcare products Regulatory Agency].
  6. Participate in the development and implementation of Global Design Quality Assurance strategy and accomplish the key performance objectives as applicable to the department.
  7. Work with global Design Quality Assurance peers and Product Development stakeholders to identify and develop improved or harmonised Product Development Quality Management System processes/systems and drive to ensure implementation within the relevant development supporting areas.
  8. Support ISO 9001/13485 compliance audit programme for the site, being the key contact for Design Quality Assurance locally. Act as representative for area of responsibility during ISO9001/13485 certification audits.
  9. Monitor and identify changes to key regulations and standards affecting compliance in relation to product and software development. Communicate changes and requirements to the site, support gap analysis and resulting implementation.

Team Management

       Manage the Design Quality Assurance team members through:

  • Setting objectives and monitoring their progress.
  • Setting performance expectations and monitoring through regular communication, the performance review process and, where necessary, through the disciplinary process.
  • Supporting team member development through development planning, coaching and mentoring.
  • Ensuring required training is completed on time and documented. 

Other

  1. Identify and produce meaningful metrics relating to Design Quality Assurance area of responsibility. Trend and progress any required corrective actions.
  2. Assemble and provide data, information and analysis for the Wilmslow site Management Review, Quality Steering Team, Executive Management Reviews, Manufacturing, Technical Quality, Supplier Business Review, CAPA meetings and other routine reports.
  3. Identify and deliver improvements to working practices within the remit of the Product Quality Assurance team.
  4. Ensure personnel adhere to the required safety standards. Maintain an appropriate environment for the occupational health of employees. 

Individual

  1. Maintain the effectiveness of the Quality system at the site via adherence to applicable policies and procedures.
  2. Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR.
  3. Identify development needs, plan how to tackle and execute plan with the support of line manager, as required.
  4. Adhere to Environmental, Health and Safety policies and procedures.
  5. Ensure all equipment used is suitable for use.
  6. Maintain an up-to-date professional knowledge of area of responsibility.
  7. Maintain an up-to-date understanding of the Waters’ organisation, it’s products and technology.

Qualifications

  1. A qualification in an Engineering/Science subject to Degree or HND level OR proven relevant experience in an Engineering/Science related function OR significant proven experience within a regulated occupational environment.
  2. Electro/mechanical and/or software product development support experience is highly desired.
  3. Strong Management skills with a focus of developing the team member skill sets.
  4. Demonstrated capability in leading a team of people in achieving goals.
  5. Good written and oral communication skills are required [for example to ensure succinct report generation, effective communication with staff, peer groups etc across organisation].
  6. Must be able to work independently and communicate with all levels of the organisation.
  7. Preferably with knowledge and experience of the execution of product development under the following environments: ISO 9001:2015, ISO 13485:2003/2016, EN ISO 14971, 21 CFR part 820
  8. Preferably with understanding and experience of the implementation of: IEC 62304, IEC 62366, Systems Engineering
  9. Computer literate, preferably with knowledge of software packages such as Word, Excel [for example produce letters, management reports, analyse data, etc].