Quality Assurance Software Specialist
4 weeks ago
Job Summary
This role is responsible for ensuring the quality of software life cycle processes, including computer software validation, and automation following Revvity's quality management system (QMS) in relevant manufacturing and clinical laboratory facilities and in accordance with 21 CFR part 11 and where applicable IEC62304.
The successful candidate 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, assisting in the Quality modules, full validation, and any necessary or desired 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 that are capable of early product approval by regulators.
- Collaborate to develop Revvity's software development and life cycle process capabilities to support agile and commercially viable development of new technologies, including AI and machine learning algorithms, instrumentation, and automation strategies.
- 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 the statistical data analysis of the Quality department KPI utilizing appropriate software tools, such as Power Bi, among others.
- Operate effectively across departmental and local boundaries to resolve Quality-related issues in collaboration with peer group and senior managers.
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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