Overview The primary function of this role is to lead and supervise the Quality Engineering group including Senior Quality Engineer(s) and Quality Engineers. Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly. Reporting to: Quality Engineering Manager Find out more about Cook Medical here Responsibilities Drive all assigned Quality Engineering projects and ensuring that 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 team at key review meetings. Work closely to build effective relationships with other functions in particular Operations, IT, Engineering and Regulatory teams. Leading the area of FDA, QSR and ISO13485 requirements, promoting, awareness of best industry practice 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. 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 prioritised and acted upon in a timely manner. Responsible for Quality systems including the following key processes within the Quality Engineering group: Design, Process and Software Validation. Supplier Quality. CAPA. Non conformances. Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes. 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 leadership and mentoring to team members to ensure the effective completion of activities associated with their role. Designee for the Quality Engineering Manager. The Quality Engineering Team Leader signature is equivalent to Senior Quality Engineer. Ensure that Cook's Code of Conduct is considered with 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 (ideally minimum 6 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. Previous supervisory experience would be beneficial. Excellent communication and inter-personal skills. Proven track record of perusing continuous self-improvement. Good working knowledge of Microsoft Office. Proven Problem-Solving Skills. 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. 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 Global General Ledger (GL) team is responsible for the accuracy and consistency of the General Ledger. The main duty of the role is GL processes with the goal of standardising, automating and managing 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 within 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 Seniority level Mid-Senior level Employment type Contract Job function Accounting/Auditing and Finance Industries Medical Equipment Manufacturing #J-18808-Ljbffr
Join to apply for the Senior Engineer, Design Control role at Cook Medical 2 weeks ago Be among the first 25 applicants Join to apply for the Senior Engineer, Design Control role at Cook Medical Get AI-powered advice on this job and more exclusive features. 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 Find out more about Cook Medical here 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Sign in to set job alerts for “Control Design Engineer” roles. 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Overview Join to apply for the Research and Development Engineer 2 role at Cook Medical . Responsibilities Perform duties of Research & Development Engineer 2: design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely and effective manner. Product testing and evaluation, and completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute toward process development during introduction/development of new equipment and production processes as required for any new manufacturing techniques. Source new materials, components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. Work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within the team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: regular communication to cross-functional teams and senior management; project status communications and reporting. Remain at the forefront of emerging industry practices. Educate oneself in the medical area for which the new devices are being developed to have an appreciation for what needs to be achieved with these products. Support other cross-functional groups to deliver company goals. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Bachelor’s degree is required, preferably in engineering or a related field. Minimum of 3 years’ relevant experience is desired. Project planning/execution skills. Execution of projects in a timely and effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of SolidWorks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards and regulations is required. 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. R&D in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. 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 Wellness program including 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 Source: IrishJobs Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical. #J-18808-Ljbffr
Join to apply for the Senior Research & Development Engineer (Vascular) role at Cook Medical Join to apply for the Senior Research & Development Engineer (Vascular) role at Cook Medical The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices for the Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Find out more about Cook Medical here Responsibilities Perform Duties of Senior Research and Development Engineer: Design development Prototyping and test method design. Design and/or process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner. Product and project risk analysis and risk management. Develop prototypes which are consistent with the clinical and design requirements of the project. Research new therapies and design solutions to develop and complement the existing product portfolio. Introduce new equipment, materials and technologies. Generation of Design History File documentation. Support of regulatory submissions. Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care. Project lead for assigned Research and Development team/s including technical and project management leadership responsibly. Lead technical development of projects. Lead all key design decisions to ensure quality design selection. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. Work closely to build effective relationships with cross functional groups to achieve project and company goals. Retrospective project reviews to understand lessons learned. Manage device evaluations. Compliance with Quality, Regulatory and company policies and systems. Mentoring, coaching and development of team members if required. Foster innovation and creativity within team and perform disclosure reviews. Ensure compliance with Quality, Regulatory and company policies and systems. Communications: Regular communication to cross-functional teams, senior management and business unit leaders. Project status communications and reporting. Remain on the forefront of emerging industry practices. Instrumental in driving and implementing change to improve departmental and company performance. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Act as a designee for the Manager, Research and Development or Team Lead, Research and Development. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Bachelor’s degree required, preferably in engineering or a related field. Minimum of 5 years’ relevant experience is required. Experience in Product Development projects within Medical Device or regulated industry/adjacent experience. Proven project/technical experience. Project management methodology and skills. Proven experience working closely with project managers. Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards. Strong statistical understanding and experience e.g. DOE and/or Gage R&R. Strong technical writer. Good working knowledge of Solidworks and/or Pro Engineer CAD. Experience of medical device development from concept through to commercialisation. Ability to effectively translate needs of clinicians and Strategic Business Unit into project inputs. 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 . Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world . Our R&D team in Limerick is split into two divisions, Vascular and Medsurg . The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch . The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies . The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. 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 br id ##IrishJobs Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Senior Research And Development Engineer jobs in Limerick, County Limerick, Ireland . 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
Join to apply for the Manufacturing Engineer 2 role at Cook Medical Join to apply for the Manufacturing Engineer 2 role at Cook Medical Get AI-powered advice on this job and more exclusive features. 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. Position: Manufacturing Engineer 2, Production Support Reporting to: Manager, Manufacturing Engineering Responsibilities 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. Development of project deliverables such as BOM’s and Production Documentation (Including IQC and Work instruction creation). 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 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cook Medical by 2x Get notified about new Manufacturing Engineer jobs in Limerick, County Limerick, Ireland . Limerick, County Limerick, Ireland 5 days ago Tipperary, County Tipperary, Ireland 1 week ago County Limerick, Ireland €55,000.00-€65,000.00 2 weeks ago Limerick, County Limerick, Ireland 3 days ago Tipperary, County Tipperary, Ireland 1 week ago Limerick, County Limerick, Ireland 2 weeks ago Manufacturing Engineer 2 (Test Method Validation) Limerick, County Limerick, Ireland 21 hours ago County Clare, Ireland €45,000.00-€55,000.00 21 hours ago Limerick, County Limerick, Ireland 4 days ago !*Senior Research & Development Engineer -Hybrid in Limerick - Exciting Medical Device!* Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 5 days ago Limerick, County Limerick, Ireland 1 week ago Sr Automation Engineer (Small Manufacturing Equipment) Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 5 days ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 1 day ago Limerick, County Limerick, Ireland 1 day ago Limerick, County Limerick, Ireland 5 days ago Limerick, County Limerick, Ireland 1 week ago Test Systems & Automation Manufacturing Engineer Shannon, County Clare, Ireland 2 weeks ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 3 weeks ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 1 day ago Limerick, County Limerick, Ireland 1 week ago Limerick, County Limerick, Ireland 2 weeks ago Limerick, County Limerick, Ireland 2 weeks ago Tipperary, County Tipperary, Ireland 1 week ago Limerick, County Limerick, Ireland 4 days 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 Manager, Research and Development will be responsible for leading Research and Development teams in the execution of product development projects in line with the Vascular Vision. This role will specifically support the embolization portfolio, leading a global project across multiple sites, with a requirement for regular travel to Denmark and the US. Reporting to: Senior Manager, Research and Development / Director, Research and Development Find out more about Cook Medical here Responsibilities Manage, schedule, costs/budget and resources for project(s) assigned. Interact with physicians for deep clinical understanding and research new unmet needs in a clinical area. Technical responsibility for all Research and Development activities assigned. Improve team processes and systems for quality and delivery of work. Identifying new vendors and strategic partners for product development and component/subassembly supply. Maintain and improve high standard of medical device engineering. Works with other Research and Development Managers, Global Program Managers and Global Directors to ensure sharing of Research and Development best practice. Manage the development of the IP portfolio for their area of responsibility. 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 performance. Manage the activities of the Research and Development Engineering team and hold regular team meetings. Foster and maintain a workplace culture respectful and supportive of individual differences. Ensure KPI’s and business metrics are achieved. Ensure the Research and Development Engineering team are in compliance with Cook’s Quality System requirements and Company HR policies. Ensure team/teams deliver quality designs in a timely manner. Foster relationships and collaborate with other functional stakeholders required for the successful completion of development projects. Must ensure effective communication of project progress and risks to all relevant stakeholders. Must work and interact effectively and professionally with and for others throughout various levels of the global organisation. Must strictly adhere to safety requirements. Must maintain company quality and quantity standards. Ability to remain calm and receptive in fast paced situations. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Bachelor’s degree in engineering or related field is required and 10 years’ relevant experience. Strong proven people management skills – a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff is desired. Proven project management skills. Strong technical writer. Good mechanical design, materials aptitude and understanding of engineering fundamentals with extensive medical device materials knowledge. Must have good understanding of IP process. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. 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. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Employee Benefits 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 #J-18808-Ljbffr
Team Lead 1, Customer Support with Spanish Join to apply for the Team Lead 1, Customer Support with Spanish role at Cook Medical 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. 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 Spanish and English. 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 Mid-Senior level Employment type Full-time Job function Information Technology Industries Medical Equipment Manufacturing #J-18808-Ljbffr
Overview Join to apply for the Regulatory Communications Specialist role at Cook Medical . The Regulatory Communications Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and related correspondence to applicable Regulatory bodies. Reporting to: Regulatory Communications Team Lead. Responsibilities Assess complaints from Cook global customer support and delivery centres for adequate information to determine if events meet Regulatory Reporting requirements. Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions. Generate appropriate regulatory reports based on assessment. Liaise effectively with regulators on all issues with regard to regulatory reporting. Ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner. Communicate with other Cook Companies globally as necessary for reporting. Generate responses to inquiries on AE reports from various global regulatory authorities. Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests. Input into the assessment of field action through the Health Risk Assessment process. Assist in coordination of Field Action administration activities between manufacturer and distribution centre. Close out of complaints as necessary. Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations. Maintain an excellent understanding of global medical device regulations. Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Performs additional duties as assigned. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Delegate for the Regulatory Communications Team Lead. Qualifications Third level Qualification in Science/Engineering desired. A number of years experience in a regulated industry in a similar role required. Thorough knowledge of the EU & US medical device regulatory requirements. Knowledge of regulatory requirements in MDSAP countries. Desirable to have knowledge of requirements in other jurisdictions. Knowledge of medical device quality standards/practises or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High self-motivation. Willingness and availability to travel on company business. Seniority level Mid-Senior level Employment type Contract Job function Marketing, Public Relations, and Writing/Editing Industries Medical Equipment Manufacturing #J-18808-Ljbffr
Overview Quality Control Inspector 1 (Evening Shift) — Cook Medical. The primary function of this role is the inspection of raw materials (IQC), finished devices (FQC), packaged devices (PKQC), sterilised devices (PSQC) and device history records (Batch Release), ensuring that inspection procedures are followed at all times and that all product and paperwork pass specified quality control requirements before shipping to customers. Responsibilities Ensure that all products manufactured at Cook Medical are inspected as per the relevant FQC instructions and meet the required quality control specifications before shipment to customers. Ensure that all raw materials received on site are inspected as per the relevant IQC instructions and meet the required quality control specifications before release for use in manufacturing. Ensure that finished goods packaged at Cook Medical are inspected as per the relevant packaging quality control instructions and meet the required quality control specifications. Ensure that products which have completed the sterilisation cycle are inspected as per the relevant instructions and meet the quality control specifications before shipment to customers. Ensure that all device history records are reviewed in line with Batch Release procedures and are compliant before product is released to stock. Ensure compliance with GMP practices (e.g., gowning correctly, adhering to CMA rules, adhering to relevant line clearance procedures, following procedures and completing paperwork accurately). Highlight any potential issues to Team Leaders. Contribute to attainment of overall KPI targets for the QC group by achieving daily/weekly quality and output targets. Work as part of a QC team within the Controlled Manufacturing Areas. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications Experience in a manufacturing environment/QC inspection role. Previous experience in medical devices is advantageous but not essential. Good communication and interpersonal skills. Ability to work as part of a team. Some flexibility as regards working hours/days. Willingness and availability to travel on company business. Seniority level Entry level Employment type Contract Job function Quality Assurance Industries Medical Equipment Manufacturing #J-18808-Ljbffr
