CYDEN

Responsibility

• adherence to audit schedules for Cyden's QMS & GMP
• adherence to audit schedules for Cyden’s QMS & GMP
• adherence to audit schedules for Cyden’s Quality Management System and Good Manufacturing Practices
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• quality assurance of new products and processes during the NPI process
• assisting with QMS improvement
• conducting audits on Cyden’s commercial partners
• successful completion of FAIR’s
• performing audits of the production quality system & device
• control of Calibration system
• assessing non-conformance for potential compliance breaches
• developing and maintaining appropriate quality instructions, specifications and standards
• issuing audit reports and notifications on any follow-up actions identified
• conducting Device Compliance Audits
• supporting quality training of production staff and acting as a quality mentor to the production team
• monitoring follow-up actions and conducting verification of effectiveness audits
• performing audits of the quality system
• supporting Third Party regulatory audits and customer audits
• recording and investigating non-conformance
• completing compliance checks for NPI, ECN's and Concession's
• completing compliance checks for NPI, ECN’s and Concession’s
• supporting resolution of quality issues, tracking and reporting on progress of corrective and preventive actions
• maintaining all required records and performance indicators
• investigation of customer returns, including analysis, reporting and progressing corrective actions
• analysing data to support quality improvement
• maintenance of the BCP
• maintaining all required records and performance indicators, analysing data to support quality improvement
• these tasks are not intended as an exhaustive list of the post holder's duties
• these tasks are not intended as an exhaustive list of the post holder’s duties
• specific responsibilities and authorities are defined in procedures relevant to the role
• ensuring effective control of non-conforming items
• working with purchasing to establish quality requirements for our suppliers, acting as the key contact with suppliers on quality issues and improvements

Requirements

• related industry experience is essential
• HNC/HND or equivalent in Electrical/Electronic and/or Mechanical Engineering would be beneficial
• ISO 9001 Internal Auditing
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• ISO 13485 Internal Auditing
• related industry experience
• essential
• proficient use of problem-solving techniques, e.g. Fishbone, 5 Why, CAPA, etc
• auditing Experience to ISO 9001
• auditing Experience to ISO 13485/MDSAP/EU MDR
• experienced in managing quality in a manufacturing environment under a comprehensive quality management system
• experience in the use of Process Flow/ PFMEA/ Control Plan/ Capability Studies/ PPAP/ etc, as part of a cross functional team
• MDSAP Fundamentals/Readiness
• HNC/HND or equivalent in Electrical/Electronic and/or Mechanical Engineering
• desirable
• MDSAP/ EU MDR Regulatory requirements knowledge
• EU MDR Requirements
• good understanding of GMP
• knowledge/experience of NPI/ECN/CAPA/Concession processes
• experience in delivering quality improvement in an electronic product or medical device assembly operation would be desired
• formal engineering qualifications
• working knowledge of ISO 13485 and validation , MRP, GD&T would be advantageous
• experience in delivering quality improvement in a manufacturing environment under a comprehensive quality management system is essential along with a good understanding of GMP

Responsibility

• cyDen is a rapidly growing Beauty tech company that has achieved remarkable success in recent years
• to strengthen our project and programme capability, we are seeking a highly experienced senior project manager
• plan, execute, and supervise projects to meet management's strategic objectives, ensuring delivery within quality, budget, and schedule
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• collaborate with various departments to ensure seamless coordination and successful project implementation
• monitor project budgets and optimize resource allocation and manage dependencies across projects for efficient execution
• effectively manage change within projects, anticipate and address potential roadblocks, and implement strategies to mitigate risks and maintain project momentum
• track project progress, set deadlines, and identify potential risks, taking responsibility for completing project work in line with the plan
• in our pursuit of continuous growth, we have developed an exciting pipeline of innovations that we aim to bring to the market in the coming years
• to strengthen our project and programme capability, we are seeking a highly experienced senior project manager with a demonstrable background of consumer product project management
• manage stakeholder relationships, including cross-functional teams, clients, vendors, and senior executives, ensuring effective communication and alignment throughout the project lifecycle
• provide leadership, guidance, and mentorship to project teams, fostering a collaborative and high-performing work environment, and facilitating professional development opportunities
• stay updated with industry trends and contribute to strategic decision-making
• meet with management to identify project requirements, delivery timelines, resource allocation, and costs
• develop detailed project schedules and Gantt charts to guide project teams, revising them as needed based on
• actively seek opportunities for process improvements, promote a culture of continuous learning, and implement best practices to enhance project management effectiveness and efficiency
• changing requirements
• compile and submit comprehensive project status reports to management, providing updates on project
• coordinate the project team, ensuring alignment, motivation, and effective communication
• conduct project closeout activities, evaluating successes and challenges to facilitate learning for future projects
• demonstrate expertise in end-to-end NPD project management, from concept creation to market introduction. IS familiar with tollgate processes
• monitor project performance to ensure timely delivery, identifying and addressing any deviations from the plan

Responsibility

• maintaining all required records and performance indicators
• effective control of non-conforming product
• leading supplier quality improvements

Requirements

• related industry experience
• essential
• excellent leadership skills/experience
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• experience leading a quality function
• excellent problem-solving skills, e.g. DMAIC, PDCA, 8D, etc
• good understanding of GMP
• desirable
• experience of electronic product or medical device operation
• good working knowledge of ISO 13485/ ISO 9001
• knowledge of Control Plan, PFMEA, CAPA, Validation , PPAP, MRP, GD&T

Earnings for position supervisor

Responsibility

• cyDen undertakes numerous clinical trials in-house and the company has developed bespoke software to facilitate this function
• all the data gathered is stored in a highly regimented format and structure to ensure accuracy and repeatability across each study
• further develop our in-house EDC solution allowing integration of various APIs
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• maintain, support, and improve the existing Image Analysis Software with a particular focus on ensuring accuracy and integrity of the data
• maintain and improve, through integration, our separate analytics software package ensuring no commercial restrictions
• cyDen is looking for a multi-skilled Software Engineer to support in the ongoing clinical trials undertaken to prove the safety and efficacy of products developed by the company
• generate one unified clinical system allowing users to move seamlessly between applications and features from set-up to data delivery
• build in key features to enhance performance; EDC, ePRO, eCOA, eConsent, API
• this software is used to manage each individual appointment, provide step-by-step guidance on the procedures to be followed along with real-time data collection at each step, the data being either captured visual images, physiological measurements via interfaced devices or questionnaire responses
• safeguard data with robust backup systems, advanced data encryption and audit trails
• maintain and improve the existing Clinical Trial Software and Hardware system, providing day-to-day support, and ensuring optimal performance and data integrity across numerous clinical suites
• provide support and infrastructure ensuring maximum performance
• the successful candidate will be responsible for maintaining and improving the existing system, providing day-to-day support and ensuring optimal performance and data integrity across numerous clinical suites
• ensure documentation is inspection ready. Documentation must meet inspection requirements and must be updated with each release
• cyDen has also developed complex image analysis tools that allow quantification of key metrics such as hair counts pre and post treatment
• these automated tools are utilised to determine the efficacy of the CyDen products using high resolution images captured during the clinical studies
• proactively support the development of a business-wide document management system that captures inputs from design/development/clinical/regulatory and manufacturing departments
• again, the candidate will be responsible for maintaining, supporting and improving the existing system with a particular focus on ensuring accuracy and integrity of the data
• key objectives/KPI's
• in addition to direct support of the clinical department, the candidate will be involved in the development of document management systems for the entire business
• streamline clinical trials making user activities/tasks easier and faster
• as CyDen operates according to numerous International Regulatory Standards, i.e., EU Medical Device Directive and the USA FDA, accurate document control is vital to the ongoing function of the business
• integrate our EDC solution with ePRO/eCOA and eConsent
• the successful candidate will be heavily involved in the development of a business-wide document management system that captures inputs from design/development/clinical/regulatory and manufacturing departments
• design solutions for study set-up, managing multiple sites and user roles
• design solutions for ISO information security management certification and FDA 21CRF compliance

Requirements

• must Have

Responsibility

• provide a robust system, including procedures, guidance and training, to achieve a sustainable risk assessment process at the Factory
• provide advice and assistance to all persons responsible for health & safety at the Factory, also supporting the Bay Studio offices if required

Requirements

• essential
• NEBOSH General Certificate in Occupational Health and Safety
• practical and up-to-date knowledge of UK health and safety legislation
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• proven experience as a HSE Advisor in a manufacturing organisation
• desirable
• provide a review of all hazards at the Factory, developing a prioritised list/programme of the risk assessments required
• induction training
• NEBOSH Diploma in Occupational Health and Safety
• undertake required risk assessments, involving relevant personnel
• emergency arrangements
• degree / HND, or equivalent, in technical discipline
• agree, track and support actions arising from risk assessments, including provision of safe systems of work / work instructions and training
• support the HR Manager in implementing an effective health and safety staff consultation process
• develop appropriate health and safety KPIs
• develop and implement a system to maintain appropriate documentation and records to demonstrate compliance all statutory requirements
• develop a programme for inspection and testing of facilities and equipment, e.g. pressure systems, LEV, lifting equipment, in accordance with insurance and statutory requirements