Verification and Validation Quality Engineer

Stem Recruitment Solutions
30 Nov 2017
08 Dec 2017
Contract Type
Full Time
STEM Recruitment Solutions are recruiting for their expanding Client who are a dynamic and energetic company developing revolutionary and flexible assay platform technologies that will transform In Vitro Diagnostic testing and provide next generation healthcare. Our Client are looking for driven and enthusiastic individuals who can add value and off a significant contribution to their continuous growth strategy. Reporting into the Quality and Regulatory Director, this role is responsible for Verification and Validation activities for an IVD platform.

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.

·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 whilst working alongside the Project Team

·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.

·Prepare and create documents and records for upload on electronic document management system.

·Review and approve Device History Records and final product release.

Essential skills

·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.

·Knowledge of statistical analysis tools.

·Ability to use problem solving tools and methodologies.

·Ability to Influence internal project team and external parties to maximize success opportunities.

Desirable skills

·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.

Hours: Monday to Friday 8.30am to 5.30pm

Excellent Benefits Package

For further information contact Stephen McDonald on 07957 676291

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