|Job Ref:||204602025||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Woodstock||Address:||Post Code:||SA63||Post Date:||24/10/2016 10:55|
An exciting opportunity for an experienced Design Control Quality Specialist has arisen with a Major Medical Device Manufacturer.|
Design Control Quality Specialist
The role is to ensure projects comply with all requirements of Design Controls
(to include CFR Part 820). This will mean working closely with R & D and the Customer in order to achieve this.
The role is key to provide Quality oversight, input and guidance on a number of projects to include:
* Responsible for verifying compliance to quality and regulatory requirements for device development and design control
* Responsible for providing quality and compliance guidance to associates in Research & Development and in Industrialisation/Operations
* Support Associates at all levels of the business to assure required documentation is completed in sequence and in a timely manner and to support continued business compliance and success
* Primarily responsible for all quality aspects for development projects and design control with key customer(s)
* Provide quality input during development and design control phases of projects in meetings, supplier visits and observing within production.
* Review and approve device development documents (e.g. design input requirements, design reviews, design verification test protocols, design verification test reports etc. ) for both new devices undergoing development and for existing devices undergoing continuous improvement
* Review and approval of qualification/validation protocols and qualification/validation reports for tools, equipment, facilities, utilities, test methods and computerised systems for the industrialisation of products and processes
* Interface with customers to understand their requirements and present the company processes and documentation to them with confidence and assertiveness
* Interface with auditors (external and internal) to confidently present processes and records to demonstrate quality compliance
Knowledge and Expertise
* Sound knowledge of current regulatory requirements for medical device (alternatively pharmaceutical) development and design control
* Knowledge of validation as well as experience with Best Practice (preferable)
* Proven experience working in medical devices.
* Knowledge of Current Good Manufacturing Practices (cGMP) requirements.
* Degree level education in scientific discipline (or equivalent experience)
Job Title: Design Controls Quality Specialist
Reference No: 228392
Job Type: Permanent
Please apply to Rachel Oliver, Senior Consultant;; (Apply online only)
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