6th October 2021 | Thomas Goepfert
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 Quality Officer 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 QMS 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 QMS 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
- 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 QMS Manager.
- Asset management and control including overseeing calibration and maintenance of assets as necessary.
- 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.
- A minimum of 2 years’ experience in working within a Quality Management System, with some specific experience of working with medical devices is desirable but not essential.
- Experience of working with ISO 13485 and ISO 14971 is desirable but not essential.
- A degree in Life Sciences is essential.
- 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 following recent commercial launch of flagship product.
- Be eligible to work full time in the UK without restriction.
QuantuMDx is a UK-based developer of transformational point-of-care diagnostics, with global operations.
QuantuMDx has developed Q-POC™ – a rapid, portable, PCR point of care diagnostic system. Q-POC™ compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device, for use at the point of care, with results in approximately 30 minutes. Q-POC™ has been designed for front-line healthcare professionals within a wide range of settings, including emergency rooms, ICU and birthing centres, clinics and pharmacies. Patients are tested, diagnosed and given treatment options in one efficient consultation.
Our first Q-POC™ test detects SARS-CoV-2, the virus causing COVID-19.
To apply for this role, please complete the form below and attach your CV. Thank you.
The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
"*" indicates required fields