to reduce or mitigate any identified risks. Maintain knowledge of site policies and procedures, especially the quality system Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements. Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative … NC, CAPAs, Change Controls, Document updates, Risk Assessments. Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status. Perform local area and local system audits. Training/coaching of operations … a medical device or pharmaceutical quality function Qualified Internal Auditor Desirable: Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001 Ability to work in matrix teams. Experience of working with multiple QMS systems Understanding of the requirements of GDPR & ISO27001 Basic knowledge of the more »
South West London, London, United Kingdom Hybrid / WFH Options
Austin Vita
reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »
maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up more »
Office including Excel, Word, Outlook, PowerPoint, Docusign, Adobe and Adobe Editor an advantage. Knowledge and experience of regulatory systems and approvals including MDR and ISO13485 an advantage. Salary & Benefits £25,000 per annum You'll receive a fantastic benefits package including pension scheme, Private Medical, healthcare cover more »
co-ordination of projects with other departments. This job will aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC. Key Responsibilities Deputy to the QM Maintain and improve quality compliance. Identify, manage, and implement continuous … interactions internally and externally. Ability to provide solutions to difficult technical issues associated with specific projects. Experience in medical device industry/Knowledge of ISO13485 & FDA QSR requirements. Knowledge of world class quality techniques and implementation. Good working knowledge of validation, data integrity, statistics, technical drawing and tolerancing. Knowledge of more »
similar. Experience in process and product validation (sterile packaging according to ISO 11607 would be advantageous). Understanding of a quality management system (ISO13485/FDA) and medical device manufacturing advantageous. Very good MS-Office skills, especially Excel. Strong organizational skills with the ability to communicate at all levels more »
a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »
