Quality Assurance Software Engineer
4 weeks ago
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) in relevant manufacturing and clinical laboratory facilities.
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 QMS and Products.
Key Responsibilities
- Manage eQMS system as per applicable standards.
- Effectively manage all assigned software life cycle process and automation projects through developing process, design, verification, and validation strategies, and associated documentation.
- Assist in the implementation, maintenance, and continuous improvement of company-wide ERP system, focusing on Quality modules, full validation, and necessary adaptations.
- 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 that yield products capable of early product approval by regulators.
- Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
- Provide quality guidance and assessment to ensure validated systems are maintained and managed in accordance with regulatory requirements.
- Responsible for statistical data analysis of the Quality department KPI utilizing appropriate software tools, such as Power Bi, among others.
Requirements
- Educated to degree level in a relevant subject or with relevant technical/practical experience.
- Knowledge on programming, coding, and use of computers with MS programs and the Internet.
- Experienced in working to GLP and Quality Management principles (ISO13485 would be an advantage).
- Attention to detail.
What We Offer
- Purposeful & inclusive work environment.
- Dynamic culture in which customers are at the forefront.
- Being part of a highly qualified team that is committed to excellence.
- Access to cutting-edge expertise through which you can make a positive impact in the world around us.
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