We are looking for a Quality Officer who will be responsible for developing, revising and implementing Quality procedures and policies for QuantuMDx Group Limited, as well as facilitating relevant company certifications and Regulatory compliance as the company enters product development and commercialisation phases. This will include maintaining ISO 13485:2016 certification and compliance with BS EN ISO 14971:2012.
The Quality Officer will also be involved in the compilation and maintenance of Device Master Records in preparation for Regulatory submissions in various markets globally and help to compile and maintain Device Risk Management Files whilst taking an active role in the risk management process.
The post holder will also:
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 a quality system to all employees.
Key Roles & Responsibilities
- 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 and rules.
- 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 13485:2016 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.
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 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™.