Validation & Quality Engineer

Blue Opal Resourcing
10 Jan 2018
09 Feb 2018
Contract Type
Full Time
We are delighted to be working with a young, vibrant, dynamic organisation, who design and manufacture revolutionary assay development platform technologies providing next generation healthcare.
We currently have an opening for a highly talented Verification, Validation & Quality Engineer, to be based on-site in our clients' central belt location.
Role Description

Reporting to the Quality and Regulatory Director, the successful candidate shall be responsible for Verification and Validation (V&V) activities for an IVD platform.
You will be responsible for the development and execution of test and verification protocols used in the commercialisation of an In-Vitro Diagnostic Instrument platform and multiple assays.
You will also be managing laboratory and test equipment in house and managing sub contract parties involved in outsourced activities. You will be involved in general day to day QMS activities associated with IVD sensors (assays) and instrumentation throughout the product life cycle.
To be considered for this role, you will be able to demonstrate the following essential skills and attributes:
  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
  • Experience of working in an IVD or medical device environment with a strong quality focus anddemonstrable, in-depth experience through development and verification and validation activities.
  • Experience of creating and executing V&V activities.
  • Experience of robustness challenging.
  • Knowledge of statistical analysis tools.
  • Experience of working on multiple projects.
  • Ability to use problem solving tools and methodologies.
  • Ability to Influence internal project team and external parties to maximize success opportunities.
In addition, it would be highly advantageous for you to have gained experience of continuous improvement (Lean, Six Sigma, Kaizen etc) and have an engineering, or related degree - equivalent commercial experience will also be considered.
This is a full-time, permanent position. Great salary (dependent on experience), and benefits on offer for the right person!
For further information, or for a confidential discussion, please apply now, or contact Angela Brown.
Blue Opal Resourcing acts as an Employment Agency for the purpose of direct placements.
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