Entrust People are currently recruiting for a Verification and Validation Quality Engineer to join a dynamic and energetic organisation who develops revolutionary and flexible assay platform technologies that will transform In Vitro Diagnostic testing and provide next generation healthcare.
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 lifecycle. Activities such as document/process creation, review and approval of documents and working with all project teams.
Key roles and Responsibilities
· Quality representative working with project teams throughout product lifecycle and product realisation activities.
· Creation of documentation forming part of the Design History File and Device Master Record.
· Assess, control and coordinate changes to Design History File and Device Master Record related to V&V.
· Participate in review the of design requirements and specifications- to plan V&V execution.
· Author and execute the product and process V&V plans and protocols.
· Management of traceability matrices.
· Participate in risk management related activities and design reviews with the project teams and ensure risk mitigations are verified.
· Author documentation for V&V in conjunction with third parties.
· Draft specifications to support supplier activities.
· Prepare and create documents and records for upload on electronic document management system.
· Review and approve as Quality representative on project teams and QMS.
· Review and approve Device History Records and final product release.
· 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 and demonstrable, 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.
· Specific or engineering experience, degree desired.
· IVD instrumentation experience.
· Knowledge and experience in electromechanical medical device Hardware and software projects.
· Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).
· Experience of applying statistical sampling and acceptance criteria.
This role offers the opportunity to join a growing organisation who are developing revolutionary technology, career development and competitive salary.