The Quality Engineer will be responsible to plan and direct all site validation and audit plan whilst also maintaining a ready state of validation compliance.
West Midlands - commutable from Bromsgrove, Wolverhampton, Dudley, Stourbridge, Kidderminster areas
This Quality Engineer will work closely with Production, Technical, Facilities, and Manufacturing Engineering departments on quality related matters such as; process control, improvement practices, and concern resolution to ensure customer and business requirements are met in a timely fashion.
o Conduct internal audits, and participate in external and third party audits
o Provide technical expertise and knowledge on process validation
o Be responsible for creating and maintaining Validation Master Plans and documentation
o Create and put into action Validation documents / protocols for new process & equipment (DQ, IQ, OQ, PQ, PPQ)
o Assist with the creation of URS's
o Create Work Instructions & SOP's
o Maintain & promote GMP
o Ensure compliance to and maintenance of ISO 13485:2016
o Manage the CAPA process
You will already have experience working as a Quality Engineer or QA Engineer and will have a sound knowledge of ISO 13485 quality systems and working with Medical Devices or similar manufacturing industry. Other Criteria Include:
o HNC or qualified through relevant industry experience
o Medical experience in a production / manufacturing environment
o Good Working Knowledge of ISO 13485 (ideally 2016) QMS
o Validation experience would be advantageous but not essential
o Good customer facing skills
o Ability to manage multiple projects simultaneously
Our client is a Medical Devices manufacturer who are experiencing a period of incredible growth and can offer a niche manufacturing service and product offering. They are now looking for a motivated Quality Engineer to join an the existing team in order to provide effective communication on Quality related issues.
This is an excellent opportunity for a Quality Engineer with knowledge of ISO13485 quality systems and auditing experience to join an expanding Medical Devices manufacturer. They are experiencing a period of incredible growth and can offer a niche manufacturing service and product offering. In return our client is offering a generous salary and benefits package plus the opportunity to make a real contribution to the success and growth of the organisation.
Apply on-line or call Robert Wigley for a confidential discussion technical-network.co.uk
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