and prepare comprehensive reports in accordance with design control standards. Background in the medical device sector to understand regulatory requirements and qualitymanagement systems (QMS) essential for successful product development. (ISO13485) Knowledge in mechanical engineering with a focus on testing equipment and innovation in product development. Requirements: Bachelor's degree more »
clinical study and FDA approval. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the QualityManagementSystem (eQMS). Contribute to the development of Work Instructions and Standard Operating Procedures (SOPs). Collaborate with the Engineering, Manufacturing and Biology teams working more »
Cambridge, Cambridgeshire, East Anglia, United Kingdom
Russell Taylor Group Ltd
ready to step up into a Principal role or an established PA looking for a change in their career. The Role: Adherence to the QMS including root cause analysis and communicating with clients on technical matters. Assistance in maintenance programs for the Departments specific analytical instrumentation and any other analytical more »
lyophilisation and quality control and production of small-medium scale batches. Handling receipt of reagents and chemicals -including aliquoting, storage and uploading onto the QMS as necessary. Working alongside CMO’s and in-house specialists to support the production scaling activities. Create and implement QC and validation protocols, ensuring that more »
will be leading the validation function to be able to execute report activities within the framework of GMP - Annex 11 & 15 in compliance with QMS requirements. In addition, they will be supporting multiple validation projects, liaising with the project departments and the associated departments to ensure work is completed in more »
Key Tasks and Accountabilities Work with the Program/Project Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint Support continuous improvements in the QualityManagementSystem (QMS) and maintain compliance of Quality processes … QA staff, provide support to departments, e.g. reporting on Quality Metrics as well as assisting in training of personnel on matters relating to the QMS and Induction of new starters on Quality aspects. Support Quality department initiatives as required, as part of a multi-disciplinary team Competencies & Requirements for the more »
Hobson Prior is seeking a Quality Assurance Specialist on a permanent basis. This role focuses on maintaining and improving the QualityManagementSystem (QMS) whilst developing diagnostic capabilities. This includes supporting internal audits, assisting with client audits, and providing support for quality department initiatives. Responsibilities: - Work alongside the team to … maintain all aspects of the QMS, including Change Controls, Non-Conformities, CAPAs, and Customer Complaints. - Support continuous improvements in the QMS and maintain compliance of Quality processes by conducting internal audits. - Assist with audits, both internally and externally, including desk-based, remote, and on-site audits of subcontractors and suppliers. more »