Overview The Global General Ledger (GL) team is responsible for the accuracy and consistency of the General Ledger. The main duty of the role is being responsible for GL processes with the goal of standardising, automating and manage exceptions. The Senior Accountant will have overall accounting responsibility for multiple entities including Cook France. The role will require significant experience, project management skills, accounting knowledge and an ability to communicate effectively. Responsibilities Overall accounting responsibility for multiple European and North American Entities. Tasks may include working with local auditors, posting journal entries, analysing accounts, doing tax returns and other Statutory returns as required. Manage Projects and Tasks within General Ledger (GL) to improve our processes and systems including but not limited to Chart of Accounts, Fixed Assets, Accruals, Prepaids, Balance Sheet Reconciliation, External audit and Coding. Responsibility for project allocations of staff cost globally Partner with Business Analysis team, Statutory team and other finance teams to ensure monthly/annual reporting is accurate. Analyse GL Entries & resolve root cause issues to ensure GL is Right First Time. Write and use GL Reports through SAP Business Intelligence system. Training, Support and Maintenance of our Chart of Accounts. Support leadership in the interpretation of financial data, tracking financial/operational objectives, and facilitating the financial reporting, planning, and forecasting process. Assist with other related Finance tasks as requested. Ensure that Cook's Code of Conduct is considered with in all business matters carried out on Cook's behalf. Qualifications Minimum 5 years continuous improvement/project management/analysis experience working for a multi-national required. Shared Service experience beneficial. Accounting qualification is a requirement (e.g. ACA, ACCA, CIMA). Exercise strong problem-solving skills during day-to-day activities. Excellent interpersonal skills. Ability to interact effectively with people at all levels and functions across the business. Ability to work well within a team environment demonstrating flexibility and adaptability as required meeting team objectives. Microsoft Office proficiency (Excel, Access, PowerPoint, Word). Second European language an advantage. Business Intelligence report writing experience beneficial. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification requirements. Characterization of processes and their outputs/acceptance criteria. Written preparation of applicable validation reports that meet regulatory/company standards. Verification testing Project management Maintain accurate and timely reports and records Must have excellent analytical and problem solving skills Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision. Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth. Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable. Deputise for Senior Manufacturing Engineer (Test Method Validation) Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree is desired, preferably in engineering or a related field and / or relevant experience. Minimum of 3 years' Validation/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. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The primary function of this role is to provide Quality Engineering 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 Department: Quality Engineering Understand and review Validation documentation, Change Requests, Design and Process FMEA's, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders. Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries. Support the Supplier Appraisal and Approval processes. Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control. Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process. Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes Conducting, documenting and reviewing complaint investigations. Risk assessment of customer complaints, Non-conformance and CAPA's. Provide quality engineering support to the Cook Medical Europe quality system. Initiate, manage and execute projects for continuous improvement within the department. Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner. Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Department: Quality Engineering Third Level qualification in Science, Engineering or a relevant technical discipline. Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage. Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive, 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. Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation. Good working knowledge of statistics. Experience in combination devices would be an advantage. Strong interpersonal skill with the ability to communicate effectively at all organisational levels. The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical Quality Systems and Processes are adhered to. High attention to detail in all aspects of the role. Excellent organisational skills. Proven problem-solving skills. High self motivation. Good working knowledge of Microsoft Office. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Get AI-powered advice on this job and more exclusive features. 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Business System Analyst jobs in Limerick, County Limerick, Ireland . Limerick, County Limerick, Ireland 2 weeks ago Shannon, County Clare, Ireland 4 days ago Limerick, County Limerick, Ireland 1 week ago County Clare, Ireland $32.00-$41.47 2 weeks ago Limerick, County Limerick, Ireland 1 week ago Shannon, County Clare, Ireland 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Overview The primary function of this position is to manage projects focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields. Reporting to: Manager, Post Market Engineering / Team Lead, Post Market Engineering Responsibilities Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives. Ensure effective reporting to the Manager, Post Market Engineering Manager. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. Provide mentorship to team members to ensure their development and the effective completion of project milestones. Responsibility for approval of design history file documentation. Lead the delivery of CAPA or Design projects with responsibility for the following: 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. Ensuring that CAPA's are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders. Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site. Identify and guide team in the successful implementation of: Design changes that will improve existing device quality, performance and efficacy. Cost reduction and yield/efficiency improvement opportunities. Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market. Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents. Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis). Support the post market surveillance of devices in terms of complaint investigation and risk analysis. Provide engineering support for post market clinical studies if required. Liaise with Research and Development teams to ensure the effective transfer of design history files for new devices from Research and Development to Post Market Engineering. Other General Responsibilities Ensure that all activities 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 Delegate for the Manager or Team Lead for document review as per Quality System Procedures. Qualifications Bachelor's degree is desired, preferably in engineering or a related field and / or relevant experience. Minimum of 5 years' relevant experience is required. 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. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid ##IrishJobs To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Team Lead, Customer Support, with Italian Join to apply for the Team Lead, Customer Support, with Italian role at Cook Medical Continue with Google Continue with Google Team Lead, Customer Support, with Italian Join to apply for the Team Lead, Customer Support, with Italian role at Cook Medical Get AI-powered advice on this job and more exclusive features. Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Work collaboratively with the relevant Manager, Customer Support to ensure that daily operations of their team(s) run effectively with a primary focus on excellent service to both internal and external customers. The scope of this role ranges from work load management to relevant HR related responsibilities. Reporting to: Manager, Customer Support Operations, (Customer Support, EMEA) Find out more about Cook Medical here Responsibilities Effectively manage the daily operations of their team(s) including phone priorities, daily and special tasks, effective query management & back order scenarios, ensuring that all daily targets and SLAs are met Effectively manage team resources, including management of leave requests Monitor adherence of team(s) to the EMEA Support Centre (EMEA SC) Quality Management System (QMS), ensuring that all procedure gaps are resolved and that daily, weekly & monthly stats are issued to the relevant parties. Work closely with the Quality team and Process owners to be audit ready all the time Focus on consistent continuous improvement within the team effort. Propose and support changes in relation to overall systems/process efficiencies. Act as the first point of escalation for individual, team, Divisional & customer issues working with relevant colleagues / leadership team to find effective solutions. Ensure effective communications by holding regular individual 1:1’s, and team meetings; and attending and providing feedback from relevant department meetings. Be responsible for recruitment, including interviewing and new hire integration into the relevant team. Be responsible for performance management of team members, including completion of annual performance appraisals and performance improvement plans where relevant as well as support disciplinary procedures where necessary. Work closely with the Training team to ensure that all team members, including new hires, are fully trained on all aspects of their roles. Highlight and address any training gaps as they arise. Coach and mentor all team members on best practice approach to their roles. Ensure that the Cook brand and image is communicated in a positive and consistent manner to all customers, both external and internal. Ensure all functions to be carried out in compliance with the company’s quality Management system. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Relevant third level qualification advantageous. In depth experience of working in a customer service environment. Previous experience working in a team leader role would be an advantage. Fluency in at least one relevant European language apart from English advantageous. Strong leadership capabilities. Proven track record in problem solving. Ability to communicate effectively on an individual and group basis. Excellent organisational and prioritisation skills. Excellent knowledge of computer software packages. Strong customer focus. Self-starter and high self-motivation. Ability to multitask, attention to detail and accuracy essential. Excellent numeric and analytical skills. Willingness and availability to travel on company business. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Customer Support Team Lead jobs in Limerick, County Limerick, Ireland . 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Join to apply for the Team Lead, Analytical Laboratory role at Cook Medical Continue with Google Continue with Google Join to apply for the Team Lead, Analytical Laboratory role at Cook Medical 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Team Lead jobs in Limerick, County Limerick, Ireland . 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Customer Support Representative 1 with French Join to apply for the Customer Support Representative 1 with French role at Cook Medical Continue with Google Continue with Google Customer Support Representative 1 with French Join to apply for the Customer Support Representative 1 with French role at Cook Medical Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google The Customer Support Representative 1 is responsible for providing a professional, friendly, and efficient service to Cook Medical customers and Divisional Sales teams throughout EMEA. Key tasks include handling customer orders accurately and within agreed service levels, while also providing timely and informative responses to customer queries. To be successful in this role, you should be an excellent communicator who gains and builds trust during all interactions who will add to our reputation as a company who offers excellent customer service. Reporting to: Team Lead 1, Customer Support Find out more about Cook Medical here Responsibilities Process all orders and other customer transactions accurately through relevant company systems within department guidelines and Quality requirements. Process all queries within department guidelines through relevant company systems. Process product complaints through relevant company systems and within the required timelines. Liaise with relevant courier companies and / or relevant internal teams as needed to ensure prompt delivery to all customers. Manage urgent and / or emergency orders / requests as they arise and communicate to the relevant teams, manufacturing plants, etc., seeking advice of more experienced colleagues as required. Log all internal and external customer feedback correctly and on time, promote the Customer Portal when possible. Maintain and update customer data as required. Liaise with Cook Medical field-based sales teams, Field based Inventory team and Supply Chain Operations teams to ensure fastest possible turnaround on all inventory, inventory returns and resolution of any inventory issues that may occur. Complete all training assigned in a timely manner to ensure required level of competence for this role and to maintain audit compliance. Take on additional tasks and involvement in the execution of new departmental projects / initiatives as trained / required. Consistently display a positive attitude towards customers and colleagues, treating everyone in a professional manner and with respect. Always ensure a high level of customer support to all customers, taking ownership for first point of contact resolution wherever possible. Maintain a supportive and communicative relationship within direct and wider teams at all times. Carry out all tasks in compliance with the Company’s Quality Management Systems. Qualifications 1 to 2 years’ experience in a multi-national customer support / contact centre environment advantageous. Fluency in French and English. Good written and spoken English language skills for those Representatives for whom English is not their mother language. Excellent telephone manner and interpersonal skills. Good working knowledge of Microsoft Office. Attention to detail, accuracy and ability to multitask. Ability to work under pressure and on own initiative with a positive attitude to problem-solving. Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Other Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Customer Support Representative jobs in Limerick, County Limerick, Ireland . 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Overview The primary function of this position is to lead and/or participate in projects focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, as well as reducing costs and increasing yields. Position: Engineer 2, Post Market Reporting to: Team Lead, Post Market, Post Market Engineering Responsibilities Lead or participate in CAPA or Design engineering projects. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with department projects / objectives. Ensure effective reporting to the Team Lead, Post Market Engineering. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory Affairs teams. Support / lead the delivery of CAPA or Design projects / deliverables with responsibility for the following: o The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved. o The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted. o The verification of effectiveness of CAPA's. o Ensuring that CAPA's are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders. o Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site. o Support projects focused on the successful implementation of: ? Design changes that will improve existing device quality, performance and efficacy. ? Cost reduction and yield/efficiency improvement opportunities. o Support Regulatory Affairs as required with engineering input for design related submissions and resubmissions post initial release of devices to market. o Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents. o Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis). o Support the post market surveillance of devices in terms of complaint investigation and risk analysis. o Provide engineering support for post market clinical studies if required. Other General Responsibilities Ensure that all activities are in compliance with: -Cook's Code of Conduct. -Cook's Quality System requirements. -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 project management skills (proven track record of same desirable). Strong interpersonal skills and the ability to communicate across functions. 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. Strong organisational, collaboration, and team building skills. High self-motivation. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview Develop and refine Cook Medical Global Design Controls, Process Development, and Risk Management quality system policies and procedures for new product development (NPD). Ensure quality system policies and procedures meet the needs of stakeholders and the expectations of regulators, in particular: Ensure the policies and procedures are compliant with applicable standards, regulations, and guidance documents. Interpret standards, regulations, and guidance documents to tailor these needs into systems which meet requirements and offer a usable approach for Cook Medical. Develop effective solutions capable of meeting global needs. Develop systems which can be operated effectively by personnel and build usability into the processes to drive robust product designs and manufacturing processes. Reporting to: Manager, Quality Assurance Responsibilities Work across Global Research and Development, Cook Medical Quality Systems, and functional stakeholders in the divisions, functional units, and operational units to develop and implement global policies and procedures for Design Controls, Process Development, and Risk Management. Develop and maintain an understanding of applicable standards, regulations, and guidance documents affect Design Controls, Process Development, and Risk Management. Coordinate implementation of global policies and procedures with local sites and Global Research and Development Operations Design Assurance personnel. Support other Cook companies as needed to implement global quality system policies and procedures. Represent Cook Medical in internal / external audits and act on assigned audit responses / CAPAs. Monitor Design Controls, Process Development, and Risk Management CAPAs and internal / external audit feedback from the manufacturing operations entities' quality systems and evaluate impacts to Cook Medical's global policies and procedures. Participate in the development and deployment of training: Develop training materials and visual aids to support procedures and policies, using smart approaches with worked examples. Coordinate and conduct training with users globally on quality system policies and procedures. Drive consistency across Cook Medical in the approaches to Design Controls, Process Development, and Risk Management. Maintain our culture, values and commitment to ethics and compliance by recognising, demonstrating, and enforcing appropriate and compliant behaviour. Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policies. Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelors Degree required in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines. Experience developing and managing policies and procedures. At least 5 years' experience working in at least one of the following areas: R&D and/or New Product Development, Process Development / Manufacturing Engineering, R&D systems engineering - Design Controls, Process Development, and/or Risk Management, Quality Assurance / Quality Engineering Effective oral and written communication skills. Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision. Experience working in a global environment / global teams across many cultures and regions, managing and executing complex projects / programs in an engineering environment. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
