Quality Assistant - London, United Kingdom - Bausch + Lomb

Bausch + Lomb

Verified Company

London, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Sterimedix is a world leader in the production of medical devices for use in eye and aesthetic surgery.

Based in Redditch, which has a rich history in needle making, the company employs over 90 people in Production, Sales, Quality, Despatch, Finance and Administration.

The Company has ambitious plans for growth based on a track record of increased sales each year. It recently moved into a new and much larger facility in North Moons Moat. The team at Sterimedix sells its products all over the world. It is a dynamic and interesting company where individuals can actively contribute to and share in its success.

General responsibilities to include:

Completion of customer quality and regulatory questionnaires in line with company procedure.
Control the new product introduction forms and track their status and report to the management team on a weekly basis.
Administration of the internal audit system, deviations and CAPA management processes.
Update Q Pulse with Product Drawings from Technical Department for approval.
Creation of Certificates of analysis for the Sales and Quality departments.
Administration and updating of technical file documentation (DOC, DMR, Biological Evaluations, Post Market Surveillance etc).
Creation / Modification / Update of internal SOPs and documents and submission for approval on Q Pulse.
Collating customer feedback and assisting with the analysis and submission into the PMS system.
Responding to customer specific requirements for Registrations.
Tracking updates to Standards and updating management, GAP Analysis.
Administering periodic environmental monitoring and reporting trends.
Assisting with the registration of company products in markets as per management request.
Administering customer communications for regulatory updates.
General administration for the Quality department and general office duties as required
Administration of the nomenclature systems for labelling and registration.
Providing data and support for the updating of department QPIs.
Helping with administering implementation of UKCA, MDR and MDSAP requirements.
Administering Contract Approval Form process.
Administration of change control process.
Creation of testing protocols to standards and test processes.
Undertake continuous training and development.
Other tasks as required to support the needs of the Quality department.