Quality Engineer

Quality Engineer - Caerphilly

*ISO13485 experience essential*

Up to £50,000 + pension & employee benefits!

Monday - Friday ( 08:30 - 16:45 )

My client based in Caerphilly are looking for a Quality Assurance Engineer to join them on a permanent basis.

This is an excellent opportunity to join a specialist manufacturing company with multiple UK depots who are going from strength to strength having experienced huge growth in the last few years, and acquired a number of companies as part of said growth.

Your role as Quality Engineer will be to maintain the Quality Management System certified to ISO 13485, ISO 14001 and MDSAP in compliance with applicable standards, legislation and directives, and ensure devices designed, manufactured and distributed are safe and effective throughout the product lifecycle.

Your key responsibilities will be:

• Maintaining the Quality Management System certified to ISO 13485, ISO 14001, and MDSAP as required.
• Performing Quality Management System internal audits, supplier audits, and environmental audits (as required). Compiling audit reports for management review.
• Maintaining the Document Control System as required
• Carrying out non-conformance and CAPA investigations, and compiling comprehensive reports as required.
• Providing training to employees in the quality management system procedures and processes when required.
• Compile weekly and monthly data summary reports for presentation to Senior Management.
• Supporting and driving product manufacturing and system process projects, and continual improvements across all areas of the business
• Taking part in external notified body audits and testing-house product quarterly inspections.
• Any other duties assigned by the Principal Quality Engineer or QA Director

You must have:

• Proven experience in maintaining a Quality Management System certified to ISO 13485.
• A working knowledge of the Medical Devices Directive 93/42/EEC
• Qualified to perform Internal Audits to ISO 13485 and (with training) to ISO 14001.
• Previous experience in using and maintaining a document control system.
• Extensive experience in compiling and updating operational procedures and work instructions
• Previous experience in a similar role

If you feel you have the relevant skills and experience, please get in touch.

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Quality Assurance / QA / Quality Systems / Quality Engineer / Quality Management / QSE

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