Our client is a progressive MedTech company passionate about creating molecular diagnostic solutions. During a period of growth they are looking for a Quality Assurance Officer to maintain and improve the company Quality Management System as part of the Quality team by identifying potential improvements and efficiencies and helping to develop, revise and implement Quality procedures and policies.
The successful candidate will work with an established Quality team to ensure products and design and development of future products are compliant with the requirements of ISO 13485 and ISO 14971 and IEC 62304.
Responsibilities *The Quality Assurance Officer will work as part of a team to ensure QA activities are completed to standard spanning QMS, Suppliers and projects
*Work with the Managers to identify and implement process improvements and efficiencies
*Manage individual projects and work packages as required related to Quality
*Prepare, conduct and record internal system audits and participate in external vendor assurance audits
*Perform supplier reviews
*Maintain and administrate the electronic Quality Management System (Q-Pulse)
*Take in interest in relevant Regulatory updates
*The Quality Assurance Officer will interact with Technical and R&D teams
*Work with purchasing staff to establish Quality requirements from external suppliers
*Ensure tests and procedures are properly understood, carried out, evaluated and documented
*Gather relevant data on QMS performance to facilitate statistical reporting
*Asset management and control including overseeing calibration and maintenance
*Investigate instances of non-conformance, propose possible suitable corrections
*The Quality Assurance Officer will help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files
*QA review of both internal and contractor generated documentation
*Take an active role in the risk management process
*Support the administration of a company-wide risk-based comprehensive training system
*Help to design and deliver training sessions to ensure the understanding and compliance
*Take an active role in software development compliance review
*Support design review and control of change processes during product development
*Participate in and report validation of QMS-related computer software packages
Requirements *Life Science experience working within a Quality Management System
*Experience of working with ISO 13485 and ISO 14971
*Degree level or equivalent practical expertise
*Ability to Travel occasionally
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales