QuantuMDx is dedicated to improving and democratising global health by providing transformative diagnostic tools to overburdened healthcare systems.
Senior QA/RA Officer
Senior QA/RA Officer
Responsible for developing, revising and implementing Quality procedures and policies for QuantuMDx Group Limited to facilitate relevant company certifications and Regulatory compliance as the company enters product development and commercialisation phases. This will include working toward ISO 13485:2016 certification and compliance with BS EN ISO 14971:2012.
Compile and maintain Medical Device Files, Technical Files and Device Master Records in preparation for Regulatory submissions in various markets globally.
Help to develop, implement and maintain Post Market Surveillance and Vigilance processes.
Maintain an up-to-date awareness of relevant legislation which may impact the QMS and communicate this effectively.
Help to implement systems that facilitate productivity, improve processes and guarantee efficacy.
Be involved in and lead training sessions to ensure the understanding and compliance of all employees.
Administer, prepare and conduct internal quality system audits and external vendor assurance audits as necessary.
Maintenance of electronic Quality Management System, Q-Pulse including monitoring and progression of CAPA and audit actions.
Promote the benefits of the quality system to all employees.
Support the validation of QMS-related software packages.
Facilitate the software engineering team with production of compliant software within our medical device.
The Senior QA/RA Officer will report directly to the Head of Quality & Regulatory Affairs.
Place of work
This role will usual be based at the Lugano Building but will be required to attend other QuantuMDx premises as necessary.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties:
- Work within the Quality team to maintain 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.
- Work with purchasing staff to establish Quality requirements from external suppliers.
- Ensure compliance with relevant national and international standards and legislation.
- Ensure policies and procedures are properly understood, carried out and evaluated and that modifications are investigated if necessary.
- Helping to train staff in Quality and Regulatory requirements.
- Facilitate the continued work toward established goals, objectives, policies, procedures and systems pertaining to the QMS.
- Work to help ensure that Quality compliance objectives and targets are achieved.
- Investigate relevant standards and establish clearly defined Quality methods for staff to apply.
- Define Quality procedures in conjunction with operating staff.
- Maintain controls and documentation procedures.
- Participate in the Company audit schedules for both internal and external Quality audits.
- Monitoring Quality indicators and helping to gather and track relevant data.
- Identify relevant Quality-related training needs and delivering training.
- QA/QC review of contractor documentation relating to validation and verification activities as well as device manufacture records when required.
- 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 is essential with direct experience working in the IVD industry an advantage.
A degree in Life Sciences is essential and experience of software validation is desirable.
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 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.