- Location: Plymouth, UK (full-time on-site initially, moving to hybrid working)
- Contract: 2 years
- Salary: Up to £50,000 per annum
Job Summary
The eDHR Systems Analyst is responsible for delivering first- and second-line support to users of the electronic Device History Record (eDHR) system at Plymouth. Operating within the Operational Technology (OT) team and reporting to the Operational Technology Leader, the role enables users to complete system transactions effectively while ensuring compliance with regulatory requirements and quality standards.
The role requires an experienced professional who understands manufacturing processes and quality management systems, combined with strong proficiency in IT and enterprise systems, to actively drive and support the digitalisation of written documents and paper-based records into electronic workflows.
The post-holder acts as the primary site contact for eDHR-related queries, incidents, rollout activities, and training requirements. Working in close collaboration with Quality, Manufacturing, and IT teams, they support the effective operation of the eDHR system and maintain efficient, compliant production processes.
Key Responsibilities
Digitalisation & System Integration
- Lead and support the translation and digitalisation of written documents, standard operating procedures, and paper-based manufacturing records into compliant electronic Device History Records (eDHR).
- Partner with manufacturing and quality teams to analyse existing document workflows and design streamlined, digitalised alternatives within enterprise and OT systems.
- Ensure digitized workflows strictly adhere to data integrity principles, quality standards, and regulatory frameworks.
Change Management
- Support the implementation of change requests relating to the eDHR system, using approved methodologies.
- Ensure all changes have the appropriate level of authorisation and documentation in line with site change control processes.
- Coordinate business process and system changes relating to eDHR, organising testing, verification, and formal approval of changes.
- Work with Project Leaders and Change Coordinators to ensure the correct, timely implementation of eDHR-related changes.
Education & Experience
- Demonstrated experience working within a regulated manufacturing environment (ideally medical devices, pharmaceuticals, or high-volume precision manufacturing).
- Strong, practical understanding of manufacturing processes and Quality Management Systems (QMS) (e.g., ISO 13485, FDA 21 CFR Part 820/Part 11, or GMP).
- Proven experience working with IT, enterprise, or shop-floor systems (e.g., eDHR, MES, ERP, PLM, or document management systems), with hands-on involvement in digitalising paper records/workflows.
- Working knowledge of formal change control and validation processes within a regulated manufacturing setting.
- Proven track record in a key functional role across Manufacturing, Quality, Operational Technology, or IT.
- Project delivery and/or quality systems training or certification is highly desirable.
Knowledge & Skills
- Strong technical capability across IT and enterprise software architectures, with the aptitude to bridge shop-floor manufacturing needs with digital IT solutions.
- Good understanding of electronic Device History Record (eDHR) systems and their role in compliant, modern manufacturing.
- In-depth understanding of Good Manufacturing Practice (GMP), data integrity, ALCOA+ principles, and regulatory requirements.
- Strong communication and interpersonal skills, with the ability to translate technical and IT concepts clearly to cross-functional, non-technical users.
- Proven ability to diagnose and troubleshoot system and user issues methodically and effectively.
- Demonstrable experience delivering end-user training and system support, either formally or informally.
- Advanced proficiency in MS Office applications and enterprise digital tools.
- Strong collaborative mindset with the ability to manage multiple competing priorities effectively.
Randstad Business Support is acting as an Employment Business in relation to this vacancy.
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