Pensions Quality Control Senior Associate - Derby, Derbyshire, United Kingdom - Guided Solutions

Description

Our client is a global MedTech company that is a manufacturing leader in infection control, decontamination and sterilization. This role will help to ensure the organisation maintains its impeccable standard of quality and regulatory assurance.

To achieve this, we have been tasked with identifying and recruiting a Quality and Regulatory Assistant to join their UK team.

The ideal candidate will have experience working with Quality Management Systems and will assist the Quality and Regulatory Manager in the establishment, maintenance and implementation of the local quality management system in order to comply with applicable regulatory requirements and established standards including ISO 13485, MDR/MDD, 21 CFR 820, REACH

Design, build and implement new quality processes into the organisation.
Drive continuous improvement in all aspects of the existing quality operation
Risk Management according to ISO14971
Assist in the implementation of clinical evaluation and technical file SOPs and review of documents associated with this.
Maintenance of medical device registrations with MHRA and EUDAMED

ISO14971/Risk Management experience required.