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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 occasionallyTo find out more about Real, please visit