Quality Assurance Software Developer

5 days ago

Abingdon, Oxfordshire, United Kingdom Revvity Full time

Role Overview

This position is responsible for ensuring the quality of software life cycle processes, including computer software validation, and automation in accordance with Oxford Immunotec's quality management system (QMS) and regulatory requirements such as 21 CFR part 11 and IEC62304.

The role will interact and work closely with the UK Quality and Regulatory team, as well as IT, Development, and ODL teams on software and automation processes and systems that impact the Company's QMS and Products.

  1. Manage the eQMS system in accordance with applicable standards.
  2. Develop and implement process, design, verification, and validation strategies for software life cycle projects.
  3. Assist in the implementation, maintenance, and continuous improvement of the company-wide ERP system, focusing on Quality modules, full validation, and necessary adaptations.
  4. Collaborate to develop and deploy regulatory and quality systems strategies in compliance with all requirements, including input to research and development programs, processes, and procedures.
  5. Contribute to the development of Oxford Immunotec's software development and life cycle process capabilities to support agile and commercially viable development of new technologies, including AI and machine learning algorithms.
  6. Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
  7. Provide quality guidance and assessment to ensure validated systems are maintained and managed in accordance with regulatory requirements.
  8. Perform statistical data analysis of the Quality department's KPI using appropriate software tools.

Requirements

Technical Skills and Abilities

  1. Education to degree level in a relevant subject or relevant technical/practical experience.
  2. Knowledge of programming, coding, and use of computers with MS programs and the Internet.
  3. Experience working to GLP and Quality Management principles (ISO13485 an advantage).
  4. Attention to detail.

Emotional Skills and Abilities

  1. Proven ability to work effectively and apply initiative.
  2. Proactive in identifying and investigating issues and presenting potential solutions.
  3. Able to work with minimal supervision.
  4. Able to handle multiple tasks effectively.

Competence Level

Professional Level

  1. Customer Focus
  2. Team Work
  3. Displaying Personal Leadership
  4. Remembering Work is about People

What We Offer

  1. Purposeful and inclusive work environment.
  2. Dynamic culture with customers at the forefront.
  3. Part of a highly qualified team committed to excellence.
  4. Access to cutting-edge expertise to make a positive impact.

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