Design Quality Engineer

Birmingham - Calthorpe Road

This vacancy is now closed

Description

 

Design Quality Engineer

Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?

Do you want to make a difference?

If the answer is ‘yes’ then you’re just the kind of person we’re looking for!

Our Quality Management System (QMS) is essential to quality compliance, it enables colleagues to appropriately manage quality requirements in a timely and accurate manner. Fundamental to this, is a clear understanding in the application and use of this system. The Design Quality Engineer ensures management of  New Product Development (NPD) &  Change Control activities are effectively reviewed and processed in a timely manner and accurately recorded.  

Duties & Responsibilities:

  • Ensuring NPD systems are followed in line with company requirements and external regulations.
  • Supporting project team activities toward meeting NPD deliverables, independently reviewing and approving design documentation, design reviews, design verification, design validation, design transfer to manufacturing, and product release authorisation for commercial launch.
  • Supporting the compliant and timely design & development, testing, verification, validation, configuration, and life cycle management of new proprietary products (including assays, software & hardware).
  • Author/revise policies, procedures, work instructions and technical documentation (specifications, protocols, scripts, and reports) relating to all aspects of new proprietary products (including assays, software & hardware) including verification and validation to meet the organizational and global regulatory requirements as well as ongoing maintenance ensuring procedural and regulatory compliance.
  • Ensuring the Change Management systems are followed in line with company requirements and external regulations.
  • Author/revise Change Management system documentation to meet the organisational and global regulatory requirements as well as ongoing maintenance ensuring procedural and regulatory compliance.
  • Leading and supporting QA projects and continuous improvement activities as required. Coordinate with the key stakeholders and multi-disciplinary teams on key projects. 
  • Maintain up-to-date knowledge of the state-of-the-art in terms of new and emerging developments relevant to industry best practices and external regulations. Lead and support the internal adoption within the business.
  • To coordinate with the QMS Training Team Leader in the delivery of NPD & Change Management system training as and when required. Work with colleagues to support manufacturing strategies. Consistently identifies and implements process improvement projects.

Essential: 

  • Educated to degree level in either a Biological Sciences, Computer Science, Engineering (or equivalent)
  • Experience of NPD / Change Control within a regulated industry
  • Experience of software development, verification & validation gained within a regulated industry 
  • Good working knowledge of Microsoft Office
  • To be friendly and approachable
  • To be flexible to the needs of the business
  • The ability to work as part of team


 Desirable:

  • Scientific, computer science or technical background.
  • Relevant experience within an IVD, Medical Device or Pharmaceutical company
  • Knowledge of data integrity principles
  • Knowledge of relevant quality standard requirements and regulations, ISO13485:2016 / ISO14971:2019 / MDSAP / IVDR / ISO27001/ IEC 62304:2006 

Working for us:

Founded in 1986 by a group of former researchers based at the University of Birmingham, Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency. 

The Company is built on the success of its people and values them as its key asset. Integral to Binding Site is creating a diverse and inclusive culture which welcomes and creates diversity of thought, action, and innovation where all 1,200 colleagues can truly thrive. Support and continuous education is reinforced through partnerships with organisations such as Stonewall.  

With a strong focus on building a sustainable future for its workforce and local communities, Binding Site has high aspirations for continuous improvement and ensuring their people contribute to their future vision. In addition, Binding Site has recently been recognised at the 2021 Birmingham Post Business Awards, winning both “Company of the Year” and “International Trade and Export” Awards.  

Location: Birmingham

Hours: 40 hrs

Benefits:

  • Competitive Salary
  • Contributory Pension
  • 25 days paid holiday plus bank holidays
  • Medicash Healthcare Plan