Location
Oxford
Closing date
20 Jan 2022

Adaptix is looking for a talented Quality and Training Officer to join its team. Working within the Quality & Regulatory Affairs department, you will plan, coordinate, and improve the quality assurance activities associated with Adaptix’s electronic quality management system (eQMS) and Learning Management System (LMS) to ensure compliance with quality and regulatory requirements. 

This is an exciting role for the right candidate as you will have an opportunity to provide support across the Quality Assurance team and make a valuable contribution to standards across the company. You will work to build and maintain assessments to evaluate the effectiveness of existing processes in supporting the company’s objectives.
 

The Company
 

Medical imaging helps patients by enabling early and accurate diagnosis.  However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies.  3D images are possible with CT scanners but these are much expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
 

At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile flat-panel X-ray systems that can be brought to patients giving low-cost, low-dose imaging. 
 

Candidate Profile
 

As our ideal candidate you have a minimum qualification in a scientific area or equivalent experience. We would welcome applications from people who have a recognised Quality Management qualification, or equivalent experience in a Quality role.

Key Responsibilities


Main duties and responsibilities

  • Lead the implementation, administration and improvement activities associated with Adaptix’s LMS covering internal and external training during new staff inductions, new training assignments and tracking documentation and course revisions and history. 
  • Creation of competency matrices, including training requirements for production staff.
  • eQMS document maintenance, including initiating and monitoring the progress of document review/approval workflows.
  • Serve as point-of-escalation for support issues, which may include interaction with LMS/eQMS vendors and other vendor support services.
  • Maintenance of eQMS documentation logs.
  • Ensure activities within the area are aligned with the company policies and best practices.
  • Work with colleagues across the company to develop state of the art training programmes.
  • Definition, monitoring, trending and report of specific quality and LMS training related objectives.
  • Contribute to generation of internal quality documentation such as quality plans, standard operating procedures, work instructions and inspection procedures. 
  • Deliver Quality training on site, e.g. Good Documentation Practice; end user LMS training.
  • Supporting non-conformance investigations, including CAPA processes and complaints.
  • Supporting quality system development and implementation.
  • Deliver Quality training on site, e.g. Good Documentation Practice; end user LMS training.
  • Supporting non-conformance investigations, including CAPA processes and complaints.
  • Supporting quality system development and implementation.

Skills Knowledge and Expertise

Skills 

  • Working knowledge of Learning Management Systems and/or eQMS and their administration.
  • Excellent organisational skills with ability to manage multiple projects simultaneously and adapt to changing priorities.
  • Ability to communicate effectively across departments and to build positive internal and external relationships.
  • Ability to analyse data, spot trends and design initiatives to create change.
  • Strong oral and written communication skills.
  • Proven time management skills.
  • Ability to work on your own initiative and have a ‘can-do’ attitude.
  • Excellent command of MS Office applications.
  • A “doer” and “finisher”.

Experience

  • Administrative experience in a highly regulated industry sector
  • Using electronic QMS management tools 
  • Working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO 14971, and other medical device related standards, ideally gained in a production environment. (desirable)
  • Qualified trainer (desirable).