The Quality Control Technician is responsible for helping to maintain the QuantuMDx Quality Management System by employing excellent attention to detail, managing time efficiently and effectively in the QC testing and inspection of QuantuMDx products:
- Execute various lab tests on product and materials, following defined methods
- Be confident in leaning new lab techniques and solution preparation
- Check incoming material documentation/certification
- Physically inspect incoming materials
- Ensure that sample traceability and status is controlled and maintained at all times.
- Support the Engineering and Assay teams in testing of incoming materials and assisting with non-routine analyses
- Assist in investigations where required
- Liaise with the Purchasing and Sales teams to ensure all materials are released in time for use
- Assist in the creation of QC processes and identifying areas of improvement
- Input into supplier complaints where required
- Ensure all documentation for incoming, intermediate and final product / materials is completed promptly and made available for batch review
- Raise QMS documentation for Change Control and Supplier Complaint, where relevant
- Assist with triggering QC inventory re-orders
- Ensure that product and materials are controlled adequately through QC processes
- Perform all activities in a safe manner with strict adherence to company guidelines
- Select product batch sample sizes as required by the procedure.
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, Development, Manufacturing, Operations, Sales and Marketing and Planning teams, where required.
- Ensure policies and procedures are properly understood and executed.
- Assist in the maintenance of process controls and documentation procedures and identify areas for improvement and efficiency.
- Support product design review and change control systems.
- Participate in the Company audit schedules for internal Quality audits.
- Monitor Quality indicators and helping to gather and track relevant data.
- Assist in the QA/QC review of contractor documentation relating to validation and verification activities as well as device manufacture records.
Experience, knowledge and requirements
- Good attention to detail
- Proficiency in Microsoft software packages
- Experience in a controlled environment of document checking and review
- Ability to prioritise and time manage
- Life Science or Chemistry qualification
- A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work with tact and diplomacy.
- Experience in working within a Quality Management System or following defined procedures.
- Be eligible to work full time in the UK without restriction.
QuantuMDx is a progressive MedTech company passionate about empowering the world to control disease and reduce suffering. QuantuMDx solves real-world diagnostic problems by creating multiplex molecular solutions for the Point of Need, for anyone, anywhere. QuantuMDx has global operations and strategic partnerships – keeping it at the forefront of molecular diagnostics.
The Q-POC™ platform is a rapid, simple to use, portable, sample to answer multiplex PCR device. It has been designed for use in a range of real-world settings, such as hospitals, clinics, pharmacies, dentistry, workplaces and in the field, providing accurate PCR results at the Point of Need.
Q-POC™ and its first test, a SARS-CoV-2 multiplex detection assay, are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. It tests multiple targets of the disease for a future proof COVID-19 testing solution at the Point of Need.
QuantuMDx plans to launch a range of syndromic multiplex testing assays over the coming months and years.
Apply for this role
To apply for this role, please get in touch via firstname.lastname@example.org, attach your cover letter and CV. Thank you.
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.