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Location

Southampton | United Kingdom

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Job description

Home > Jobs > Quality and Regulatory Engineer

Quality and Regulatory Engineer

Job Description

Our client is looking for a Regulatory Engineer who can mark CE custom-made devices to the Medical Devices Regulation and managing these regulations. This includes creating and maintaining the relevant technical files and updating the product user and technical instructions for use. This role will maintain the upkeep of ISO9001 and ISO14001 manuals in conjunction with the ISO consultant and keep the Health and Safety policies up to date in conjunction with changes within manufacturing processes.

Key Responsibilities and tasks:

• Create technical files for all products in line with the MDR
• Produce all requirements to fulfil ISO 9001
• Produce all requirements to fulfil ISO 14001
• Ensure all NCR and quality assurance forms are processed and recorded correctly
• Produce and update work instructions for all products they manufacture
• Communicate daily both externally with suppliers and internally with all levels within the company using appropriate communication skills and methods to deliver the message effectively.
• Put in place quality checks for the standard of the Technician’s work ensuring it complies with the company’s processes, CE standards and ISO 9001.
• Initiate, develop and implement any process changes that would optimise efficiency within the Workshop.
• Possibility of flexible start and finish times
• Life insurance
• Free Parking

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