Overview The primary purpose of this position is to manage and support Aortic- CMD product lines. Including creating strategies for market development and growth in the region, creating sales concepts to increase market share etc. while working closely with the marketing teams, business management and divisional support in each local market. As an individual contributor, you take direction to execute the regional marketing plan for the assigned specialty in alignment with the division's mission, vision and purpose, and overall company priorities. Consistently collaborate with key stakeholders to execute the assigned specialty vision and strategy in alignment to meet the needs for each region, while incorporating feedback from the field and customers. The position will report to the Manager, Market Development. The position can be plant based at William Cook Europe in Denmark or at Cook Ireland or it can be field based if you are already working in a field-based role. Responsibilities Collaborate with key stakeholders to establish, measure, and meet business plan goals for assigned specialty and geography. Support accelerating market adoption for the assigned specialty. Provides product & market support. Responsible for being the regional product champion/expert. Collaborate with key stakeholders to ensure consistent messaging for the assigned specialty. Support conversions with key customers for the assigned specialty. Answers sales & customer questions for the assigned specialty. Support product launch, campaign planning & execution. Provide consistent program-related field communications. Present launch content to sales & support internal sales meetings. Collaborate on sales tools and messaging needs. Create market updates to send to the field. Responsible for customization of large accounts. Responsible for actively engaging CRM as a key tool for communication & sharing customer & market insights back into the organization. Initiate focus campaigns in cooperation with sales. Identify and develop relationships with SME's to advance for the assigned specialty. Support for ordering congress materials / samples - regional or specialty shows. Responsible for delivery of marketing materials for reimbursement due to updates or change in information. Support sales training & develops marketing tools and materials Meet deadlines and complete administrative duties such as expense reports, training, reporting, policy acknowledgments, etc. in a timely manner. Conduct Cook business with integrity and in compliance with applicable standards and Cook policies. Within the scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met. Qualifications 5-7 years of relevant experience in sales, marketing and/or product management. Extensive sales, marketing and/or product management experience. Demonstrated deep knowledge and experience with relevant products and market. Prior experience in leading organizational change preferred. Demonstrate strong strategic business skills. Demonstrate strong leadership skills. Prior experience leading organizational change. Model the company standards that others are expected to follow and demonstrate positive and constructive behaviours that drives achievement. Intermediate skills in Microsoft Office Higher level degree in related field and/or equivalent relevant experience desirable. Ability and willingness to travel on company business up to 50%. 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 Tender Representative 1 is responsible for working with Cook Medical Divisions & other relevant departments within Cook Medical, to ensure that Tenders to supply Cook Medical products to the European Market are submitted in a timely and accurate manner. This role is also responsible for ensuring Cook Medical product pricing is updated on the relevant systems. Reporting to: Team Lead 1, Customer Support Responsibilities Prepare quotations received from Customers & Cook Medical Sales teams and send written price confirmation to the Customer as required / appropriate. Search for potential tender notices relevant to Cook Medical's business. Work with key stakeholders within Cook Medical Divisions to ensure Tenders are submitted within customers' specific deadlines and requirements - focussing on less complex Tenders. Oversee the compilation to ensure that tenders and bids are handled professionally, quickly, and compliantly. Support colleagues on more complex Tenders as required. Work with other departments within Cook Medical globally as required to gather information relevant for tenders - e.g., Finance, Marketing, Manufacturing, Regulatory, Logistics, etc. Maintain accurate Tender files for historical & reference purposes, including information relating to awards, alterations & extensions of contracts. Update Pricing on relevant systems as necessary to allow for accurate order entry Complete all training assigned in a timely manner to ensure required level of competence for this role and to maintain audit compliance. Provide guidance and assistance to colleagues as appropriate / able based on training and experience. Take on additional tasks and involvement in the execution of new departmental projects and initiatives as trained / required. Consistently display a positive attitude towards customers and colleagues, treating everyone in a professional manner and with respect Ensure that all duties are carried out in compliance with the company's Quality Management System. Qualifications Experience or knowledge of Pricing, Tenders or Public Procurement advantageous. Legal or Business qualification advantageous. Fluency in Italian and English. Excellent written skill in the relevant languages. Excellent organisational & prioritisation skills. Ability to work under pressure & towards tight deadlines. Strong research & analytical skills. Attention to details, with clerical speed & accuracy. Ability to multitask. Strong customer focus (Internal & External). Positive attitude and proven problem-solving skills. Excellent telephone manner & interpersonal skills. Computer literacy: Good working knowledge of Microsoft Office; Experience of Pricing& Tenders Software advantageous. Willingness and availability to travel on company business. Flexible start time to accommodate European time zones. 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 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 - Customer Support Centre Operations 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. 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.
Customer Support Representative 1 with Italian Join to apply for the Customer Support Representative 1 with Italian role at Cook Medical Customer Support Representative 1 with Italian Join to apply for the Customer Support Representative 1 with Italian role at Cook Medical Get AI-powered advice on this job and more exclusive features. 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 Italian 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 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, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and associated 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 event meets 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. Ensuring 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. 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 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 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 #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.
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.
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.
