Waters Corporation

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Quality Officer, Document Control

Quality Officer, Document Control

System ID 
7185
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 Corporation is currently seeking a Quality Officer, Document Control to join our company.  This is a fantastic opportunity for an experienced Quality Officer to join a global medical device company working within a state of the art facility in Wilmslow.

  

The successful candidate will be responsible for managing and supporting documentation review/approvals and designing, implementation and maintenance of processes to ensure continual improvement of processes and conformity to ISO 9001, 13485 standards and CFR requirements.

  

The successful candidate will also report on the performance of the Quality Management System (QMS), our Regulatory Compliance and identify and drive any improvements needed and analyse and act on Quality trends and manage/resolve quality issues.

 

The role requires a high degree of cross-functional working to provide Quality support to all site functions (e.g. Production, Design, Product Management) and communicate any issues to Senior Management.

 

This is an ideal role for a quality professional seeking to take the next step in their career and it offers an excellent benefits package and the opportunity for further training and development.

Responsibilities

  • Perform day-to-day Document Control activities (e.g. document author, review, approval) and coordination of QS processes (e.g. Change Management, Hard Copy Control, Periodic Review, Record Retention, External Control of Standards).
  • Identify and implement new, or changes to existing, process/system improvements in accordance with the requirements of ISO 9001, 13485, 21 CFR parts 11 and 820.
  • Conduct internal audits in accordance with the internal audit schedule.
  • Produce and co ordinate weekly/monthly/quarterly metrics, analysis of quality data to identify trends and recommend and facilitate corrective/preventive actions and generation of quality reports.
  • Provide guidance, support and training to internal customers on quality system processes and tools.
  • Manage and administrate quality system related changes to the document/change management systems.
  • Determine the root cause of Quality System related non-conformance investigations, recommending corrective/preventive actions and progressing to closure.
  • Cross-functional working with Global teams to improve and align quality system processes.

Qualifications

  • A qualification in an Engineering/Science subject to degree or HND level OR proven relevant experience within a regulated occupational environment.
  • Proven knowledge and experience in document control systems.
  • Working knowledge and experience of applying ISO 9001, 13485 and 21 CFR part 820 standards and regulations within the Medical Device or IVD industry is essential.
  • Must be able to work independently and as part of a team and communicate with all levels of the organisation.
  • Good written and oral communication skills are required, for example to ensure succinct report generation.
  • Demonstrated practical approach towards problem solving.
  • Flexible attitude and capable of working under pressure to tight and changing deadlines.
  • Excellent attention to detail required.
  • Knowledge of continuous improvement techniques desired.
  • Experience of participation in internal and/or external audits desired.
  • Computer literate, preferably with knowledge of software packages such as Microsoft Word, Excel, PowerPoint, TrackWise, SAP etc.