Position overview
The Quality Officer is responsible for helping to maintain and improve the QuantuMDx 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 the 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.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties:
- Maintain a positive attitude and assist the line Manager to ensure deliverables are achieved within target timelines.
- Champion the highest level of quality & process and undertake training in order to develop.
- Work with the Manager to identify and implement process improvements and efficiencies.
- Manage individual projects and work packages as required.
- Communicate effectively with all teams and functions within QuantuMDx.
Technical Delivery
- Prepare, conduct and record internal system audits and participate in external vendor assurance audits.
- Perform regular supplier reviews.
- Maintain and administrate the electronic Quality Management System Q-Pulse.
- Promote the benefits of a quality system to all employees.
- Take in interest in relevant Regulatory updates including contributing to assessment for impact on the company’s QMS.
- Effectively interact with Technical and Development teams to ensure research and development is performed in accordance with company procedures.
- Work with purchasing staff to establish Quality requirements from external suppliers.
- Ensure tests and procedures are properly understood, carried out, evaluated and documented and that modifications are investigated if necessary.
- Gather relevant data on QMS performance to facilitate statistical reporting where requested by the Manager.
- Asset management and control including overseeing calibration and maintenance of assets as necessary.
- Investigate instances of non-conformance, propose possible suitable corrections, corrective and preventive actions. Review and advise on potential instances of non-conformance.
- Participate in 3rd party audits of QuantuMDx.
- Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files in preparation for Regulatory submissions in various markets globally with guidance from the Regulatory team and the CEO.
- QA review of both internal and contractor generated documentation relating to development, verification, validation as well as device manufacture and production records.
- Review and archival of records.
- 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 of all employees.
- 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.
- Work within the rest of the Quality team to maintain focused, effective progression in line with Company Quality objectives.
- Support the Quality team by attending and providing feedback on training and mentoring activities.
- Perform other duties that may be required from time to time.
Time Management
- Ability to manage multiple conflicting activities to deliver on time.
- Be receptive to delegated priorities and direct their own activities whilst supporting the team’s activities.
- Identify risks to delivery, look for mitigating actions and inform line and senior management.
Experience, knowledge and requirements
- A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
- Industry experience working within a Quality Management System, with some specific experience of working with IVD medical devices.
- Experience of working with ISO 13485 and ISO 14971.
- A degree in Life Sciences or equivalent.
- Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
- Good sense of humour and ability to adapt to a changing environment.
- Be eligible to work full time in the UK without restriction.
Company Overview
QuantuMDx is a progressive MedTech company passionate about point-of-need molecular diagnostics. Our mission is to make transformative, quality diagnostic technologies accessible to everyone, so that diseases can be detected and treated earlier.
The Q-POC™ is a simple to use, portable, sample-to-answer multiplex PCR device. It has been designed for use in a range of settings providing rapid, accurate results directly to the healthcare provider at the point-of-need.
Working together with strategic partnerships, the Company will be introducing Q-POC™ 2.0 in the near future, keeping us at the forefront of rapid molecular diagnostics.
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