Quality And Regulatory Engineer

Quality and Regulatory Engineer

Salary - £37,500 - £40,000 per annum

Permanent, Full Time

Totton, Southampton – free parking

Consolor is looking to recruit a Quality and Regulatory Engineer based out of our site in Totton, Southampton. This role is responsible for CE marking all Consolor’s class 1 medical devices and ensuring all of Consolor’s custom-made devices also meet requirements as set out in the Medical Devices Regulation (MDR) and managing these regulations.

Consolor is an innovative, forward thinking and exciting company, committed to the assessment, manufacture and provision of specialist seating and mobility products and services to NHS and private clients across the UK.

Day to day you will be responsible for managing and updating QMS processes to be compliant with the relevant standards; ISO: 9001 & ISO 14001.  This will involve reviewing current documentation from product development, determining requirements and Regulatory pathway whilst creating documentation for regulatory filings of new product development.

This role will require you to be hands on and practical with the ability to support and train the further Consolor team. The successful candidate will also be responsible for producing written work instructions, conducting quality investigations on all non-compliances using the 5 Whys methodology reporting the findings of the root cause corrective action and implementing these actions.

The ideal candidate will:

• Have significant Quality and Regulatory experience
• Knowledge and understanding of ISO9001, ISO14001 and necessary regulations.
• Be an enthusiastic, motivated individual who strives to succeed with excellent communication skills, liaising with all stakeholders as required.

Interested in this Quality and Regulatory Engineer / Manager role? Please apply with your updated CV.

INDHS