We’re looking for a QA/RA Officer to help maintain and improve QuantuMDx’s Quality Management System. Working as part of our Quality team, you will identify potential improvements and efficiencies and help to develop, revise and implement quality procedures and policies.
Alongside the Quality team and wider design development team, you will work through the design, development and launch of the Q-POC™ platform, which will include compliance with the requirements of ISO 13485:2016 and BS EN ISO 14971 and IEC 62304.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties you will:
- 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 administer the electronic Quality Management System, Q-Pulse.
- Promote the benefits of a quality system to all employees.
- Take an 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.
- 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 VP QA/RA.
- QA/QC review of both internal and contractor generated documentation relating to development, validation and verification activities as well as device manufacture records when required.
- 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.
- Promote the benefits of the quality system to all employees.
- 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.
- Ability to manage multiple conflicting activities to deliver on time.
- Be receptive to delegated priorities and direct your 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 good understanding and experience of working with ISO 13485 is essential with direct experience working in the IVD industry an advantage.
- 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 as the company matures and moves from the R&D stage into commercialisation.
- Ability to work full time within the UK without restriction.
- Experience of working in compliance with ISO 14971 is an advantage.
To apply for this role please send a cover letter and CV to moc.xdmutnauq@tnemtiurcer.
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™, 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 may be used as standalone devices or integrated into diagnostic workflows. Products include the pathogen enricher CAPTURE-XT™.