life style benefits, package
7 months ago
Acting as the Quality manager you will be working closely with the VP of Quality & Regulatory to scope out a quality Training plan / training matrix for staff to follow. Must be able to understand and support the transition of the new MDD and MDR Regulations for 2021 as you will be leading the development of internal procedures to ensure continuous compliance with relevant regulations.
Minimum 3 years experience in a Quality Assurance Role in the Medical Device /Pharmaceutical Industry.
Working knowledge of ISO 13485:2016, the MDD and the MDR .
Knowledge of Quality Management Systems (QMS)
Experience of Quality systems to include but not limited to Change Controls, Complaints, Deviations, CAPA.
Responsible of the following tasks:
Involved in the Regulatory Affairs & Quality Department, to implement the new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements
Support the maintenance of the Company's Quality Management System
To adapt existing procedures and documents that best meet the requirements of QMS within the Company
Reporting and investigation of Non-conformance's/deviations and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures
To support with the Quality Training plan / training matrix and the implementation of training (MDR, GDP) throughout the company, with relevant follow-up
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be the perfect fit for you.
or 01737 761 697