Overview The primary function of this role is to provide technical leadership within Quality Engineering to help provide support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development, and Engineering Sustaining teams. This includes but is not limited to providing support to process validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, Design and Process FMEA, risk assessment, and associated Quality System Documentation. Reporting to: Team Lead, Quality Engineering Department: Quality Engineering Responsibilities Drive all assigned Quality Engineering projects and ensure they are managed in a structured fashion and completed in compliance with the relevant procedures. Manage and drive project activities to ensure timely completion of project milestones. Represent the team at key review meetings. Work closely to build effective relationships with other functions, in particular Operations, IT, Engineering, and Regulatory teams. Lead in the area of FDA, QSR, and ISO13485 requirements, promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Quality Engineering Manager as the final arbitrator on critical quality decisions. Identify and implement opportunities for improvement and implement under their own initiative. Maintain a proactive approach to developing Cook’s Quality system to meet the changing needs of the business. Ensure that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner. Demonstrated proven experience and proficiency across functional areas: Design, Process, Risk Management, Software Validation, Supplier Quality, CAPA, Non-conformances, Customer Complaints, Sterilisation, Statistics, Facilities/Environment, Microbiology/Biocompatibility, 6 Sigma/Lean/Continuous Improvement. Support the Internal Audit, Supplier Audit, and Regulatory Audit Programs. Prepare, execute, and analyse Quality Engineering Documentation. Trending and analysis of key Quality metrics. Responsible for the assessment of risk throughout Quality Engineering key processes and systems. Provide mentoring to team members to ensure the effective completion of activities associated with their role. Assist the Quality Engineering Team Lead/Quality Engineering Manager to ensure the appropriate allocation of resources and prioritization of efforts. Delegate for the Quality Engineering Team Lead/Quality Engineering Manager. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Third level qualification in Science, Engineering, or relevant technical discipline. Proven knowledge and experience (minimum 4 years at QE level) of working with ISO13485, ISO14971, EU Medical Device Regulation 2017/745, and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. Excellent communication and inter-personal skills. Proven track record of pursuing continuous self-improvement. Good working knowledge of Microsoft Office. Proven Problem-Solving Skills. Taken lead in technical negotiations. Influence others in problem solving/issue resolution. Good working knowledge of statistics. Knowledge and experience of all aspects of validation. Excellent organisational, time management, and presentation skills. Excellent attention to detail. Proven self-starter. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview The Senior Data Analyst examines and interprets data to identify trends, patterns, and insights that can help the business make better decisions. They are also responsible for designing and maintaining data-driven solutions. This role utilizes tools such as Power BI, PowerApps, and SharePoint to develop intuitive reports and automate workflows to ensure seamless data integration across regions. By collaborating with global, cross-functional teams, the role delivers actionable insights, enhances decision-making, and drives continuous improvement. Additionally, the role explores AI technologies, automation, and advanced analytics to future-proof solutions and optimize global performance. Responsibilities Data collection - use statistical methods and tools to analyse data and identify meaningful patterns. Gather relevant data from various sources, including databases, surveys, and external resources. Clean and prepare data for analysis, ensuring accuracy and consistency. Data Insights & User-Centric Reporting - Leverage data to create insightful reports and dashboards that are user-friendly for non-technical audiences. Reporting – Complete comprehensive reports and, when applicable, present data-driven recommendations to the business, including Senior Leadership. Collaborative End-User Design & Implementation – Work closely with end users and key business stakeholders to design custom dashboards, reports, and visualizations. Custom PowerApps Development & Maintenance - Lead the design, development, and maintenance of custom PowerApps solutions, tailoring applications to meet evolving business requirements. Ensure these solutions are intuitive, scalable, and secure, providing long-term value to end users. Application Support & Maintenance (PowerApps & Power BI) - Provide end-to-end support for the PowerApps and Power BI environments, ensuring they remain user-friendly and secure. Manage the full lifecycle of updates and new feature rollouts, conducting / coordinating thorough testing, troubleshooting, and user acceptance testing (UAT) to ensure smooth transitions with minimal disruption. Develop and maintain a process to manage change requests to reports, dashboards and visualizations. Automate processes for efficiency - Implement automation solutions to streamline repetitive tasks and reduce manual effort where possible, e.g. in daily report generation, creation of visual outputs for tiered levels of customer support, etc. SharePoint Management - Design, create, and manage SharePoint sites and lists that support various business processes. Ensure these environments are well-structured, user-friendly, and maintained based on input from stakeholders, allowing for effective collaboration and data management. Ability to collaborate with internal teams where relevant, to connect data sources across different platforms using APIs or connectors to ensure seamless flow. Global Project Involvement & Communication - Actively participate in global and regional projects as required, collaborating with diverse teams across regions to meet project objectives. User Training & Documentation - Provide hands-on training on tools / apps / processes introduced helping users to gain confidence in using the solutions developed. Maintain comprehensive documentation of processes, workflows, and systems to support onboarding, troubleshooting, and future development efforts. Exploring AI & Advanced Analytics - Investigate the potential use of AI and machine learning in reporting and data automation to identify opportunities for predictive analytics and enhanced decision-making. Work with Cook AI to learn and implement AI technology into the business, where applicable. Continuous Improvement: Lead and oversee Continuous Improvement efforts by finding opportunities for data processes. Qualifications Bachelor’s degree in business, Computer Science, Analytics, Information Systems, or another related field. Minimum of 3 years of relevant experience preferable. Proficiency in data analysis tools. Ability to analyse complex data sets, identify trends, and draw meaningful conclusions. Strong knowledge of relational databases and data modelling. Excellent analytical, problem-solving, and innovative thinking skills. Working experience with SQL, Qlik, Power BI and Power Apps. Knowledge of ERP & CRM systems (e.g. Salesforce, Oracle) for data extraction and integration. Exceptional knowledge of MS office, particularly MS Excel. Demonstrated ability to work on own initiative, drive deadlines, balancing multiple priorities, and ensuring quality standards. Experience communicating technical details to technical and non-technical resources as well as translating complex data into actionable insights. Experience in managing data related projects. Proven ability to work cross functional and co-ordinate the efforts of multiple global stakeholders. Flexible collaborator with a positive attitude towards problem solving. Willingness and availability to travel on company business where required. #J-18808-Ljbffr
The Manufacturing Engineer 2 will be responsible for key activities across a variety of manufacturing engineering disciplines, namely New Product Introduction, Process Improvement, Production Support and Production Maintenance. Key activities will include leading projects to either introduce or support and improve existing products. More specific details are listed below for the specific roles. Reporting to: Manager, Manufacturing Engineering Find out more about Cook Medical here. Responsibilities Production Maintenance Develop and implement maintenance strategies for new and existing production equipment. Ensure Preventative Maintenance and Calibration activities are relevant, value add and will lead to optimised equipment performance. Planning and scheduling of maintenance and calibration (both scheduled and unscheduled) tasks in conjunction with Operations department. Development of aged equipment, spare strategies and tooling criticality assessments. Responsible for the Equipment Manager role within the INFOR EAM system and be an SME for INFOR in CIRL. Ability and willingness to interact with various functions to problem solve and address equipment/maintenance issues. Ensure that manufacturing engineering maintenance and calibration activities are carried out according to company operating procedures and are compliant with Cook Medical quality system. Liaise with other Cook Manufacturing Facilities to achieve homogenous processes across the group and ensure best in class maintenance activities are in place for CIRL. Lead/support with production equipment issue resolution through Green Belt or Problem-Solving events as required. Prepare, review, and approve change requests and other quality system documentation requiring production maintenance engineering sign-off. Plan and execute projects to ensure that project timelines, quality and cost targets are met. Process Improvement Identify and undertake projects focused on the successful implementation of: o Process changes that will improve existing device quality, performance, and efficacy. o Cost reduction and yield/efficiency improvement opportunities. Provide engineering input and support for the investigation and resolution of Non-Conformances associated with devices post release to market. Support Regulatory Affairs as required with engineering input for process related submissions and resubmissions post initial release of devices to market. Provide engineering input and support to those responsible for Vendor instigated changes (Supplier Change Notifications). Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles. Responsible for process engineering layout plans and implementation in relation to line extensions or redesign. Support the post market surveillance of devices in terms of complaint investigation and risk analysis. Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI. Collaborate with other Engineering teams to ensure the effective completion of all activities associated with an Engineering project/objective. Ensure effective reporting to the Manager Manufacturing Engineering. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory Affairs teams. Lead or participate in engineering tasks focused on the support/completion of CAPAs, process validations and pFMEA activities. Support and/or lead the introduction of new products into CIRL directly from design or transfer from a sister entity. Support and/or lead Continuous Improvement activities to deliver benefit to key business metrics. Development of project deliverables such as BOM’s and Production Documentation (Including IQC and Work instruction creation). Production Support Source and install new equipment requirements into manufacturing in accordance with Cook Medical’s quality system. Work closely with the Machine Shop to develop jigs, fixtures, and tooling to improve Manufacturing efficiencies. Support with defining maintenance and calibration requirements for manufacturing equipment both new and improve existing in accordance with Cook Medical’s quality system. Prepare, review and approve change orders and other quality system documentation requiring manufacturing engineering sign-off. Develop Work Contents for Manufacturing Flow lines by completing Time studies, removing nonvalue add waste and Generating standard of work. Plan and execute improvement projects to ensure that project timelines, quality and cost targets are met. Deputise for Manufacturing Engineering Manager/Manufacturing Engineering Team Lead. New Product Introduction Lead or give direction to process development activities for assigned projects focused on New Product Introduction (NPI). Ensure that new products are developed in accordance with DFM principles. Ensure that new products/processes integrate with CIRL MFG Operational Unit current and future systems. Lead or technical lead for transfers from Cook sister companies. Accurate definition of Bills of Materials and product capacity requirements. Drive project tasks to ensure timely completion of project milestones and business metrics. Complete/support retrospective project reviews to understand lessons learned. Lead activities that will: o Improve device quality, performance, and efficacy. o Result in cost reduction and yield/efficiency improvements. Work closely to build effective relationships with cross functional groups to achieve project and company goals. Collaborate to provide technical expertise across multiple projects or teams in a specific area or subject matter expertise. Support Regulatory Affairs as required with engineering technical expertise for design/manufacturing related submissions and renewals post initial release of devices to market. Remain on the forefront of emerging industry practices in areas of subject matter expertise. Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies. Other General Responsibilities Ensure that all activities are in compliance with: o Cook’s Code of Conduct. o Cook’s Quality System requirements. o Company HR policies. Liaise with other Cook manufacturing facilities as required. Qualifications Bachelor’s degree is desired, preferably in engineering or a related field and/or relevant experience. Minimum of 3 years’ relevant experience is required. Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation. Willingness to seek out and drive improvement. Proven project planning skills and the ability to execute projects in a timely and effective manner. Team Player with ability to develop strong working relationships. Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence. Must be able to work in a fast-paced environment. Excellent attention to detail. Knowledge of relevant ISO, EU, FDA medical devices standards regulations is required. High self-motivation, self-starter with a passion for excellence. Good working knowledge of Microsoft Office. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview The primary function of this position is to manage a team of Engineers & Technicians focused on process improvements of devices post release to market and/or the introduction of new products (NPI), for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields. Reporting to: Manager, Manufacturing Engineering Responsibilities Responsibilities: Lead a team of engineers focused on any one of the following Manufacturing Engineering areas (detailed below) as required - CAPA, Design, Manufacturing or NPI. Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role. Team Management: Mentoring, coaching and development of direct reports to attain best performance. Perform routine appraisals to deliver best results and to obtain the maximum team. Manage the activities of the Manufacturing Engineering/NPI team and hold regular team meetings. Ensure KPI’s and business metrics are achieved. Work with Manufacturing Engineering Manager and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Manufacturing Engineering team. Collaborate with other Manufacturing Engineering Team members to ensure the effective completion of all activities associated with a Manufacturing Engineering project/objective. Ensure effective reporting to the Manufacturing Engineering Manager. Work closely to build effective relationships with other functions in particular Production, Quality, Regulatory and R&D teams. Manufacturing/Process/CAPA/New Product Introduction (NPI) Responsibilities: Identify and guide the team in the successful implementation of: Process changes that will improve existing device quality, performance and efficacy. Cost reduction and yield/efficiency improvement opportunities. Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market. Provide support and technical guidance for the Supplier Change Notification (SCN) process. Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market. Responsible for process engineering layout plans and implementation in relation to line extensions or redesign. Support the post market surveillance of devices in terms of complaint investigation and risk analysis. Provide support and guidance to engineers and technicians focused on the support/timely completion of CAPAs (related to design, procedures and systems, or manufacturing processes). The completion of the Investigation/Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved. The identification and implementation of appropriate corrective/preventative action, and collaboration with other functions to ensure same if they are impacted. The verification of effectiveness of CAPA’s. Liaise with R&D and Process Development teams to ensure the effective and efficient transfer of new devices from Development to Manufacturing. Provide guidance and leadership on NPI projects to ensure successful and timely completion of same. Other General Responsibilities Ensure the Manufacturing Engineering team are in compliance with: Cook’s Code of Conduct. Cook’s Quality System requirements. Company HR policies. Liaise with other Cook manufacturing facilities. Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies. Responsible for operating general internal quality systems and documentation. Act as a Designee for the Manager or Snr. Engineer for document review as per Quality System Procedures. Qualifications Formal production/engineering qualification and/or relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development/CAPA. Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff. Strong interpersonal skills and the ability to communicate at all levels of the organisation. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Excellent organisational and team building skills. High self-motivation. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview The Senior Manager, Supply Chain Manufacturing is responsible for the Supply Chain for Cook Ireland (CIRL), owns the SIOP process and leads the local procurement and planning teams in Cook Ireland. The role includes responsibility for all Procurement and Planning activity and Supplier Management responsibilities in alignment with the Global functional direction. Position: Senior Manager, Manufacturing Supply Chain Reporting to: Director, Manufacturing Operations Responsibilities Develop, implement, and execute strategic materials management processes in support of supply chain and business objectives – see the future; mitigate risk; optimize inventory for the CIRL Entity. Lead transition to enterprise-level platform solutions in accordance with global strategy. Lead the local SIOP review process through the planners and represent CIRL on Global SIOP process teams, leveraging tools and systems to support goals and objectives. Work with order management, sales & marketing, product managers, manufacturing, suppliers, distribution centres and third-party logistics provider in support of business objectives. Lead and drive the Continuity of supply forum to ensure no disruption to supply for our customers. Lead discussions in supply related matters to drive corrective action while working with cross-functional counterparts. Drive alignment across procurement and Planning Team to help them optimize performance, resolve issues and develop improvement strategies to sustain Best in Class performance. Oversee & ensure that supply is protected to support manufacturing operations, while driving inventory reduction and optimisation initiatives. Point of escalation as required to negotiate with suppliers on agreements or new business opportunities. Support R&D in onboarding of new suppliers and establishing cost estimates for raw material requirements. Collaborate with legal to support contracting activities; review master agreements, statements of work, change orders, or similar documents as directed by the category team or site leadership. Manage freight expenditure for all aspects of CIRL. Provide Logistics/Commercial support to activities relating to supplier selection and evaluation. Assess supplier capabilities through business discussions etc. Liaise with other Cook Medical manufacturing sites and distribution centres on Supply chain related issues. Ensure that procurement activities are executed in line with category guidance, and in compliance with relevant global policies, standards, guidelines, and operating procedures. Collaborate with approved suppliers globally and locally. Actively participate within a cross functional team to understand business requirements and execute based on procurement process. Ensure above functions are carried out in line with internal Quality procedures, ISO 13485 and FDA QSR. Seek out continuous improvement best practice with an emphasis on what can be learned and implemented at Cook Ireland to drive a best-in-class operation and efficient processes. Work and interact effectively and professionally with and for others throughout various levels of the global organization. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Act as a delegate for the Director of Operations for change control review as per Quality System Procedures. Qualifications Qualifications / Requirements: Degree in relevant discipline desired. 10+ years’ experience in supply chain and strong knowledge of ERP systems desired. In general should have 7+ years of management experience, ideally within the medical device industry. Must be knowledgeable of Supply Chain systems, tools, policies and procedures. Demonstrated experience in negotiations, driving cost reduction strategies and day-to-day procurement operations. Knowledge in demand planning and inventory management. Excellent communication skills. Proven problem-solving skills. Ability to prioritise workloads in a fast-paced environment. Good working knowledge of Microsoft Office is a prerequisite. Availability and willingness to travel on company business as required. #J-18808-Ljbffr
Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners, or regulatory authorities. Reporting to: Team Lead, Regulatory Affairs or Manager, Regulatory Affairs Find out more about Cook Medical here. Responsibilities Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned, such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21CFR Part 820. Knowledge of relevant ISO, EU, and FDA medical device standards regulations is required. Ensure a thorough understanding of the products and/or regions they are assigned. Communicate country/region specific regulatory requirements. #J-18808-Ljbffr
Overview The primary purpose of this position is to lead a team of Quality Control Inspectors in a production environment. Reporting to: Manager, Quality Control Find out more about Cook Medical here Responsibilities Responsible for Quality Control of medical devices within Cook Medical including inspection of raw materials, in-process product, finished and sterilized devices. Ensure that the work done by quality control personnel is in compliance with the requirements of the quality system. Prepare or review SOP’s manufacturing/quality control instructions, which are required by the quality team. Ensure that a high standard of cleanliness is maintained in the manufacturing areas in order to control product bio burden. Ensure that changes to relevant procedures/instructions are relayed to those affected in production. Ensure that training needs of employees in the QC area are constantly reviewed and that required training is given as appropriate. Monitor employee performance and carry out performance appraisals with employees. Maintain excellent communication channels with the production team and with other departments. Work closely with other departments to meet delivery requirements. Take ownership for assigned customer complaints, CAPA’s and determine root cause. Monitor rejects from quality control processes and disposition through MRB process. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Level 8 in Manufacturing Engineering or related discipline preferable. Minimum 5 years previous experience in a supervisory position desirable. Strong communication and inter-personal skills. Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards. Knowledge of Lean Manufacturing desirable. Good computer skills including knowledge of Microsoft Office. Excellent organisational and team building skills. High self-motivation. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview The Regulatory Scientist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs). The Regulatory Scientist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Scientist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities. Reporting to: Senior Manager Post Market Surveillance, Regulatory Affairs or Principal Regulatory Scientist Responsibilities Maintain an excellent understanding of global medical device regulations in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). Implement regulatory requirements in accordance with EU MDR 2017/745, ISO13485, MDD 93/42/EEC, FDA QSP 21CFR Part 820 and others as required. Create and conduct systematic literature searches using search databases for published literature (Embase, PubMed etc.). Write clear and effective search protocols and reports. Appraise clinical data relating to State of the Art (SOTA) and non-clinical and clinical data relating to Cook Ireland medical devices. Author Clinical Evaluation Protocols (CEPs) and Clinical Evaluation Reports (CERs) in accordance with internal procedures, ensuring the relevant regulatory requirements are addressed. Input and adhere to the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations. Maintain appropriate regulatory records to demonstrate compliance with applicable regulations. Liaise and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensure the outputs from the individual functional units meet the applicable regulatory requirements. Review and analyze data for same. Prepare relevant information/responses for regulatory submissions, working with other members of the RA department. Review & analyze adverse event/complaint information where required. Ensure, in conjunction with Medical Affairs and other personnel, that the clinical requirements of the product are adequately addressed. Participate in development projects and prepare project deliverables, including literature search and examination of clinical evidence. Provide input to risk assessment and product labeling as well as clinical/regulatory strategies. Communicate directly with Notified Bodies, Competent Authorities and other Regulatory Authorities as required. Act as the Regulatory representative for participation in internal and external regulatory audits. Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required. Perform additional duties as assigned. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned. Ensure a thorough understanding of the products they are assigned. Communicate country/region specific regulatory requirements to the regulatory specialists/managers. Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel. Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market. Plan and prepare regulatory submissions for specific target markets for new products and product changes as required. Communicate the clinical requirements for regulatory registrations for the product and work as part of a cross-functional team to ensure that they are adequately addressed. Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required. Serve as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Provide support to currently marketed products as necessary including input on change requests, etc. Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations. Provide regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution. Perform additional duties as assigned. Can act as a designee for the Regulatory Affairs Specialist or Regulatory Affairs Senior Scientist if required. Qualifications Third level Qualification in any of the following areas: Science, Engineering, or Clinical, such as Pharmacy or Nursing, desired. 2 years’ experience in a regulated industry in a similar role would be advantageous. Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form. Participate in a team-based environment. Proven problem-solving skills. Good technical writing skills; advantageous to have medical writing experience. Knowledge/use of search databases for published literature (Embase, PubMed etc.). Good computer skills including knowledge of Microsoft Office. Proven organizational skills. High level of self-motivation. Willingness and availability to travel on company business as required. #J-18808-Ljbffr
Overview The Team Lead, Analytical Laboratory will be required to coordinate and supervise all activities involved in the running of an efficient and effective analytical laboratory. Responsibilities To coordinate and supervise all activities involved in the running of an efficient and effective Analytical laboratory including scheduling of testing and release of product from the laboratory upon completion of testing. To provide technical and problem solving support to the team as required. (Knowledge of UV Vis, Dissolution and HPLC Equipment and techniques are a prerequisite). In depth knowledge of Agilent HPLC’s, Empower and Chemstation Software required. Carry out project work as required, particularly associated with the implementation of new specifications and methods of analysis required to comply with pharmacopeia or customer requirements. Co-ordinate Stability Programme. Manage the maintenance and calibration of analytical equipment and review and approval of associated documentation. Also ensure laboratory CFR21 Part 11 adherence and qualification of new equipment. Evaluate the finished product and raw material analysis prior to shipment/use and completion and approval of associated documentation. Maintain acceptable work standards (e.g. safety, environmental, cGMP housekeeping etc.) agreeing targets and objectives and evaluation of achievement of these objectives. Review and Approval of Laboratory Investigations and CAPA’s in a timely manner. Ensuring laboratory audit readiness at all times and participate in audits (internal and external) and inspecting as required. To identify training gaps present in the team and take necessary measures to close these gaps and ensure this training is documented as per company procedures. Review performance achievements, formally and informally, with the team members with a focus on improvement. Ensure all laboratory documentation is kept up to date. Delegate for the Manager, Analytical Laboratory once trained on relevant procedures/tasks. Provide monthly reports and Quality Metrics in a timely manner. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications BSc / Masters desirable and/or relevant experience. Excellent technical knowledge of the team’s area of responsibility. Previous supervisory experience desirable Ideally a minimum of 5 years experience within a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry. Excellent organisational skills are required for this role. A minimum of 5 years analytical laboratory experience. Proven People management, problem solving and leadership skills. Computer literacy. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview The primary function of this role is to assume responsibility for systems/process analysis, process development, process implementation and continuous improvement across the Manufacturing and Distribution ERP system. Find out more about Cook Medical here Responsibilities Work closely with specified user areas to assist in the identification of process improvements, system design, testing and implementation of MRP projects, often requiring coordination of multiple functional areas. Support business transition to Oracle ERP through data and business process readiness. Site Oracle SME development to provide training expertise to relevant functions within CIRL to support business transformation. Identify, evaluate, and implement operational changes to improve information and processing systems. Analyse and define user requirements and translate them into system requirements to ensure understanding of the request by all project members. Demonstrate accuracy and thoroughness when identifying and defining requirements. Organise and participate in requirements meetings. Constantly improve current system reporting and drive CI ethos on all reporting, and improvement of system effectiveness/robustness. Produce visual representations (flowcharts) of conceptual solutions. Co-ordinate and Execute User Acceptance Testing (UAT) protocols across many functional areas. Develop technical training programs and conduct user training. Develop system procedures for operation of new systems. Solve process related support issues, ensuring solutions are cross business effective. Reviews enhancements and projects after implementation to ensure compliance to specifications, and cost-effectiveness. Review and provide recommendations on major projects and system enhancements. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Business, Engineering or IT Degree preferred. Min 3 year’s experience in hi-volume manufacturing environment. Oracle operational experience is beneficial and participation in successful ERP Implementation would be a significant advantage. Strong communication skills, both verbal and written. Strong business systems knowledge and experience working closely with IT, Finance and Manufacturing. #J-18808-Ljbffr
