
Quality Engineer 2
3 weeks ago
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 Find out more about Cook Medical here 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.
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Quality Engineer 2
4 weeks ago
Limerick, Limerick, Ireland Cook Medical Full timeJoin to apply for theQuality Engineer 2role atCook MedicalJoin to apply for theQuality Engineer 2role atCook MedicalGet AI-powered advice on this job and more exclusive features.The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and...
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Manufacturing Engineer 2
7 days ago
Limerick, Limerick, Ireland Cook Medical Full timeJoin to apply for the Manufacturing Engineer 2 role at Cook MedicalJoin to apply for the Manufacturing Engineer 2 role at Cook MedicalGet AI-powered advice on this job and more exclusive features.The Manufacturing Engineer 2 will be responsible for key activities across a variety ofmanufacturing engineering disciplines, namely New Product Introduction,...
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Manufacturing Engineer 2
3 weeks ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Find out more about Cook Medical here 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...
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Research and Development Engineer 2
2 weeks ago
Limerick, Limerick, Ireland Cook Medical Full timeOverviewJoin to apply for the Research and Development Engineer 2 role at Cook Medical.ResponsibilitiesPerform 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...
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Research And Development Engineer 2
5 days ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical.Position: Research & Development Engineer 2 Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Research & Development Engineer 2:...
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Research & Development Engineer 2
5 days ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical.Reporting to: Team Lead, Research and Development / Manager, Research and Development Find out more about Cook Medical here Responsibilities Perform Duties of Research & Development Engineer 2: Design...
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Senior Engineer, Equipment Engineering-2
2 weeks ago
Limerick, Limerick, Ireland Analog Devices Full timeOverviewJoin to apply for the Senior Engineer, Equipment Engineering-2 role at Analog Devices.Location: Limerick, County Limerick, Ireland. This role will be situated in our cleanroom class 10 Wafer Fabrication facility at the Limerick site, and the successful candidate will perform the duties described below.ResponsibilitiesSupport daily operation of the...
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Research & Development Engineer 2
4 days ago
Limerick, Limerick, Ireland Cook Medical Incorporated Full timeOverviewThe primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical.Reporting to: Team Lead, Research and Development / Manager, Research and Development Find out more about Cook Medical hereResponsibilitiesPerform Duties of Research & Development Engineer 2:Design...
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Quality Engineering Leader
6 days ago
Limerick, Limerick, Ireland beBeeQuality Full time €90,000 - €120,000Job OverviewA high-impact Quality Engineering Team Lead role is now available, offering a unique opportunity to lead and supervise a talented team of Quality Engineers. The successful candidate will be responsible for setting objectives, creating training plans, coaching team members, conducting performance appraisals, and addressing performance-related...
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Quality Engineering Team Lead
1 week ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview 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....