Reporting to the Head of QA & RA, the QMS Manager is responsible for the day-to-day running of the QuantuMDx QMS including authoring, revising and implementing Quality procedures for QuantuMDx Group Limited to facilitate relevant company certifications and Regulatory compliance as the company nears the commercialisation phase. This will include compliance with the requirements of ISO 13485:2016 and BS EN ISO 14971. The QMS Manager will:
- Oversee the compilation and maintenance of Device Risk Management Files and take an active role in the risk management process.
- Implement systems that facilitate productivity, improve processes and guarantee efficacy.
- Take a lead role in the development and administration of a company-wide risk-based comprehensive training system.
- Be involved in and lead training sessions to ensure the understanding and compliance of all employees.
- Administer, prepare, conduct and record internal system audits and external vendor assurance audits.
- Performance of regular supplier reviews.
- Maintenance of electronic Quality Management System Q-Pulse.
- Promote the benefits of a quality system to all employees.
- Keep up-to-date with and inform higher management of relevant Regulatory updates including contributing to assessment for impact on the company’s QMS.
- Management of a team of Quality Officers with diverse backgrounds and varying levels of experience, contributing to their personal and professional development.
Key Roles & Responsibilities
- Management of a team of Quality Officers to ensure focused, effective progression in line with Company Quality objectives.
- Effectively interact with Technical and Development teams to ensure research and development is performed in accordance with company procedures.
- Working with purchasing staff to establish Quality requirements from external suppliers.
- Ensuring compliance with relevant national and international standards and legislation.
- Ensuring tests and procedures are properly understood, carried out and evaluated and that modifications are investigated if necessary.
- Training of staff in Quality and Regulatory aspects.
- Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QMS.
- Maintenance and control of Company Audit schedules for both internal and external Quality audits.
- Monitoring performance by gathering relevant data and producing statistical reports.
- Asset management and control including overseeing calibration and maintenance of assets as necessary.
- Administration of the CAPA system including recording and investigating instances of non-conformance.
- Participating in 3rd party audits of QuantuMDx.
- Identifying relevant Quality-related training needs and delivering training.
- Perform other duties that may be required from time to time.
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.
Experience of working with ISO 13485, ideally 2016 version and in the IVD industry and experience in training staff.
A degree in Life Sciences.
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 as the Company matures and moves from the R&D stage into commercialisation.
Ability to work full time within the UK without restriction.
To apply for this role please send a cover letter and CV to HR@QUANTUMDX.COM.
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.
QuantuMDx Group is one of the most exciting life sciences, tools and diagnostics companies to emerge from the UK in recent years. Due for commercialisation in 2018, their signature device, Q-POC™, is a low-cost, simple-to-use, portable diagnostic device for 10 – 20 minute diagnosis at the patient’s side. The robust device will identify the presence and strain of an infection, ensuring the right drug is prescribed first time, facilitating a more intelligent use of antibiotics. Further to this, globally distributed Q-POC™ devices will geotag and anonymise pathogen data, sending it to the cloud for real-time disease and drug resistance monitoring, and rapid detection and containment of pathogens.
Q-POC™ is ideally suited to help address the humanitarian health burden by offering gold-standard molecular diagnostics at a fraction of the price of traditional testing. Once the device has passed regulatory approval it will be available for highly multiplexed diagnostic and drug susceptibility testing for just a few dollars, in any setting globally.