Quality Systems Analyst Medical Devices Plymouth Permanent Contract Focus of the role Principally to manage and control quality system documentation and eQMS consisting of Standard Operating Procedures, drawings, work instructions, procedures, material specifications, product specifications, artwork, and other various documents such as deviations, changecontrol and document … control. Responsible for the management of the Quality Management document control system (including eQMS). Performing Internal Audits and maintaining resultant reports. Issuing and verifying corrective and preventative actions. Role Responsibilities Responsible for understanding the company quality policy and performing functions in accordance with documented quality procedures. Perform all … document and record responsibilities including change control. Establish support and awareness to change requestors in defining changes, evaluating the impact. Review completeness of documentation ensuring compliance to all relevant requirements. Facilitate implementation assessments to determine document control and training impact to ensure right first time. Support and more »
and Programmes adhere to the structure. * Own and maintain governance templates and logs (Weekly Status, Portfolio Governance Forums, Risks & Issues, Dependencies, RESA, Investment Case, Change Request, Actions and Decisions). * Ensure strict adherence to ChangeControl processes whenever a deviation is required from a baselined deliverable, including … ensuring integrity of baseline information for projects and programmes; such as budgets, milestone dates, investment approval phases. * Oversee the administration of Projects' Investment and ChangeControl Processes, to provide assurance that all the projects in the portfolio are appropriately governed and changes to baselined deliverables across the portfolio more »
Configuration Engineer, you will ensure that configuration data and documents are accurate, valid, and fit for purpose at all times. You will coordinate configuration changecontrol forums and create and distribute various configuration management information. Your expertise will support the design and production engineering environment by managing CM … of product configuration information for all lifecycle stages. Perform gap analysis on baseline status for planned baseline release and governance gates. Support the design changecontrol process forums, scheduling ECR/ECN approval as required. Ensure all ECR/ECN submissions meet defined quality and completeness criteria prior … to approval. Provide guidance on the creation and progression of ECR/ECN change vehicles. Create and maintain Configuration Status Accounting and Configuration Items Lists records. Administer and provide user support to the project/product team regarding PLM tools and CM processes. Support and/or carry out more »
Somerset, England, United Kingdom Hybrid / WFH Options
Vulcain Engineering - UK
pre-construction readiness to ensure that design, materials, temporary works etc are available at pre-determined lead times. Drive the timely resolution of Field Change (FCR’s), Non-Conformance (NCRs), Request For Information (RFIs) and any other constraints to delivery that the Construction Leads require support on. Conduct Project … Client’s obligations under the contract are discharged in a timely manner. Lead activities required to comply with HPC Project Governance, including progression of ChangeControl (PCR’s) as appropriate. Skills, Experience & Qualification: Track record of delivering projects within a technically complex and dynamic environment whilst ensuring high … in managing/developing: Engineering design, contract and field execution strategies for project delivery. Multi-discipline EPCM projects, Procurement and management of complex contracts. Control of costs; risk; schedule and change and proficient in the use of Earned Value tools, Close out of commercial claims and the associated more »
Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance and CAPA, change management, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review Take ownership for assigned projects … for accuracy and compliance with cGDP and MDD/MDR. This will include, but is not limited to, review of project documents, specifications, BOMs, change controls, validation protocols and standard operating procedures (SOPs), custom pack documentation & packaging submissions. To support the supplier assurance program including the approval of suppliers … Establish, implement and support the maintenance of the Labour Standards Assurance Scheme (LSAS) Support the changecontrol process. Give QA oversight and provide support to activities within the company (UK) Support the risk management process and liaise with key stakeholders to reduce or mitigate any identified risks. Maintain more »
Main Contract commercial management; Negotiating and agreeing applications for payment and final accounts. Complying with the clients contract. Managing the commercial aspects of a change register, managing changecontrol procedures, identifying and pricing variations, agreeing additional costs with both clients and supply chain. Reporting; Production of monthly … site teams with commercial and contractual support. How to Apply This is a good opportunity to join a progressive company where you can commercially control a broad variety of minor civils projects. Please apply on-line or contact Paul Chaffe or Fiona Corbett on 01179 349555 for more information. more »
Somerset, England, United Kingdom Hybrid / WFH Options
Vulcain Engineering - UK
plans including full costing, development of WBSs, resource management, cost management of risk and critical path review, using appropriate software and tools Manage the changecontrol as the project/programme scope changes, using the correct processes and updating the necessary configuration documentation Understand the need for project … baseline control and different types of baseline change Understand the tools assess project performance and quality against the baseline schedule Understand risk and opportunities and integrate the cost of these strategies effectively into the plan/schedule Understand project control methodologies and processes for programme and project more »
Bridgwater, England, United Kingdom Hybrid / WFH Options
Vulcain Engineering - UK
plans including full costing, development of WBSs, resource management, cost management of risk and critical path review, using appropriate software and tools Manage the changecontrol as the project/programme scope changes, using the correct processes and updating the necessary configuration documentation Understand project control methodologies … managing construction/manufacturing related projects. Experience of managing NEC and/or FIDIC contracts. Able to demonstrate strong management skills including financial, risk, change, engineering, and schedule. Appreciation of Safety, Environmental and Quality requirements in a highly regulated environment. Benefits: Hybrid working Private medical & dental insurance Enhanced maternity more »
Master Schedules (IMS) and Performance Management Baselines (PMB) for all bids. Input and track data from controls Foster a continuous improvement culture within Project Control processes. The ability to establish and meet deadlines, multitask, and prioritise without the requirement for regular direct supervision. Good stakeholder management capabilities, with excellent … Planner/Project Controller, ideally within the defence (or similar sector) Experience using Primavera P6 to create and maintain Integrated Master Schedules (IMS), conduct ChangeControl, Forecasting, Deploying KPIs, Variance Analysis, Risk & Opportunity Management, Project Governance and Project Reporting. You will bring structure to complex situations, have a more »
City Of Bristol, England, United Kingdom Hybrid / WFH Options
Vulcain Engineering - UK
plans including full costing, development of WBSs, resource management, cost management of risk and critical path review, using appropriate software and tools. Manage the changecontrol as the project/programme scope changes, using the correct processes and updating the necessary configuration documentation. Understand the need for project … baseline control and different types of baseline change. Apply the principles of Earned Value Management (EVM). Essential or Desirable Skills and Abilities Knowledge of the below are essential: Project management tools and techniques Planning software e.g. Primavera P6, MS Project Cost Software e.g. SAP Risk Software e.g ARM more »
work closely with internal and external stakeholders to develop and implement project controls processes and systems. Your role will involve managing project schedules, cost control, risk management, and performance reporting. You will play a key role in ensuring that projects are delivered on time, within budget, and in accordance … with quality standards. Responsibilities Manage the project controls team Project Planning Risk management Cost and changecontrol Governance, reporting, and lessons learned Requirements Essential Previous experience as a project controls manager or planning manager Strong understanding of project management principles and methodologies. Expert Knowledge in in P6, Microsoft more »
Master Schedules (IMS) and Performance Management Baselines (PMB) for all bids. Input and track data from controls Foster a continuous improvement culture within Project Control processes. The ability to establish and meet deadlines, multitask, and prioritise without the requirement for regular direct supervision. Good stakeholder management capabilities, with excellent … Planner/Project Controller, ideally within the defence (or similar sector) Experience using Primavera P6 to create and maintain Integrated Master Schedules (IMS), conduct ChangeControl, Forecasting, Deploying KPIs, Variance Analysis, Risk & Opportunity Management, Project Governance and Project Reporting. You will bring structure to complex situations, have a more »
DRM) and Product Specifications Product and Process FMEAs/Risk Assessments Customer Complaints Medical Device Risk Management Reports and Files Quality Inspection Procedures and Control Plans Quality Systems and Process SOPs and Work Instructions (PWI). Conduct internal Audits, GMP and process audits, as required. Supervise goods in inspection. … methods, instructions. To actively provide quality support in batch records review and ensure correct batch release process. To actively support training. To actively support changecontrol process. To provide quality support for manufacturing improvement projects. The jobholder has no budget setting responsibilities. Any spend is subject to QM more »
from experienced professionals and launch your own career path within a business that is going places. RESPONSIBILITIES Support in the development, implementation, 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 … Actively participates and/or drives Quality System improvements as required. Supports continuous improvement initiatives, process improvements to address operational issues using statistical process control (SPC) and Quality tools e.g. pareto, process capability, correlation analysis, etc. Performs internal and supplier audits as required. Uses auditing as a proactive tool … as SME during external regulatory audits. Strong knowledge and experience of CAPA and NC for medical devices A practical working knowledge of implementation of changecontrol, and of all aspects of the process and equipment validation lifecycle Desirable Requirements Knowledge and experience of PowerPoint and SAP and SPC more »
solutions. System upgrades, planning, implementation and testing. Present proposed and completed developments to product owners, project teams and other stakeholders. Ensure adherence to the Changecontrol process. Develop a good understanding of the needs and requirements of the end users. Responsible for dealing with development, system integration and more »
developing construction sequences and recovery plans. • Good working knowledge of commercial principles affecting construction matters. • Ability to produce informative, concise reports. • Awareness of project changecontrol and risk management processes. • Extensive working knowledge in the delivery of large complex construction projects. • Experience and understanding of using solid modelling more »
3D library of custom and third party supplier’s components containing relevant attribute data for use by site teams in their federated models. Information, ChangeControl & Records The senior DE modeller for site is ultimately responsible for ensuring that the site teams always have access to the latest more »
Cheltenham, Gloucestershire, South West, United Kingdom
Jefferson Wells
artefacts to ensure requirements are correctly met. * Awareness & ideally experience of some of the following; requirements, design, architecture, verification (manual & automated scripts), traceability, baseline & change control. Qualifications/Requirements * Experience of the system design lifecycle within Aerospace, automotive or similar complex product * Prior experience working in a team * A more »
whole life costs, etc.). Preparation of tender documentation and the administration of tender processes. Preparation of contracts. Post-contract cost management (e.g., administering changecontrol processes, valuing variations, assessing contractor's claims). Preparing valuations for progress payments. Preparation of post contract cost reports. Preparation of final more »
and manage procurement events to secure all necessary contracts for successful portfolio delivery. Lead on post contract management, including management of early warnings, contract change and change control. Work collaboratively with internal design teams and supply chain partners to successfully delivery project outcomes. Profile Qualifications, Skills, Experience & Attributes … other project management methodologies. Strong NEC3 contract administration experience. Ability to interrogate project programmes (P6 and/or MSP). Strong financial management/control experience. YOU MUST HAVE THE RIGHT TO WORK IN THE UK Desirable: Chartered Project Manager NEC Project Management Accreditation What’s in it for more »
projects. * Excellent interpersonal, organisational and communication skills, verbal and written. * Good commercial knowledge and experience - understands contracts and able to manage internal and external change effectively. * Good knowledge and experience of implementing and operating Project Governance, Controls and Reporting including Planning, Risks/Issues, Finance and Change Control. … Knowledge of project financial processes including experience of project cost control and ability to interpret and report financial data and analysis. Key Success Measures * Integrate into the established Project structure. * This is a 'Client-Side' role within the core Project Leadership Team. Support and deputise where necessary for the more »