QuantuMDx is dedicated to improving and democratising global health by providing transformative diagnostic tools to overburdened healthcare systems.
QuantuMDx Temporary QMS Manager – Maternity Cover
Temporary QMS Manager (Maternity Cover)
Commencing June/July 2018
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 email@example.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 an exciting and highly innovative multinational company headquartered in the United Kingdom, with operations and partners in the United States, Asia, Europe and Africa.
The Company’s technology innovates the molecular diagnostic work-flow, enabling delivery of rapid actionable answers to complex clinical questions at a price point accessible to both high and low resource settings.
The Company’s flagship device is the Q-POC™, due for commercialisation in 2019, a simple-to-use, affordable, portable sample to answer molecular diagnostic device. With its laboratory quality testing and cost-effective disposable, Q-POC™ will bring the power of precision medicine to health professionals throughout the world, regardless of location or budget. Moreover, with its best in class multiplexing technology, it enables rapid detection of antimicrobial resistance and subsequent ‘right first-time prescribing’.
The company is developing further diagnostic platforms that can be used as standalone devices or integrated into diagnostic workflows. Products include pathogen enricher CAPTURE-XT™ and rapid sample preparation kit DNA-XT™.