Quality Engineer II
3 days ago
I am partnering with an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD) are looking tohire a Quality Engineer II as they expand operations. The Role: This position requires experienced and proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial. Development and supporting Quality Management System (QMS) activities, batch release, internal audits, and supplier management. Responsibilities: Responsible for compliance with Policies and Procedures and applicable National and International Regulations. Leads compliance and improvement activities associated with thequality system (e.g. CAPA, audit programs, personnel training). Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required. Provide expertise in the areas of quality assurance, controls and systems to support and develop the QMS. Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements. Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics. Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial. Gather and analyse data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirements Prepare and maintain detailed records of inspections, testing, and non-conformance reports. Collect, analyse, and report key data related to product testing, supplier performance, and internal quality metrics. Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency. Develop test protocols or reports to support the design validations and verification activities. Support the quality control activities, relating to lot release of finished devices, received products or other QC activities. Review and approval of changes to product, processes for existing medical device products are conducted in compliance with global regulations and internal procedures. Requirements: A degree in quality engineering, life science or related field. 3-5 years experience at a quality assurance role in the medical device sector essential, preferably in a FDA/MDR regulated environment. Quality certification and lead Auditor certification an advantage. Knowledge of FDAs 21 CFR Part 820 (Quality System Regulation) and ISO In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.). Experience in the QA activities associated with the design and development of medical devices. Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment. Excellent interpersonal skills and ability to work with people to achieve results. Excellent written and communication skills, fluency in English, attention to detail and strong technical writing skills. Proven record of policy and procedure development. Good judgment/decision making and problem-solving ability, Highly motivated with excellent communication skills and proven ability to work effectively as part of a team an interact professionally with all organizational levels. Proficiency in MS office products. Good business acumen and an enthusiastic self-starter. For more information and a confidential discussion on the role, please contactMichelle Mc Inerney. Skills: Quality Operations Engineer
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Quality Engineer II
4 weeks ago
Galway, Ireland Sterling Engineering Limited Full timeQuality Engineer II Responsibilities:Ensure compliance with customer and regulatory quality systems (ISO 13485, FDA).Develop and maintain effective inspection plans for incoming, in-process, and final products.Investigate and resolve quality issues, including customer complaints, using CAPA systems.Assess product/process changes for validation and quality...
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Quality Engineer II- Medical Device Start-up
4 days ago
Galway, Ireland Wallace Myers International Full timeMy client who are an exciting Galway based medical device start-up are seeking a Quality Engineer II to join their team. This position requires 3+ years' experience in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial launch. The role includes development...
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Design Assurance Engineer II
1 week ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team. The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety,...
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Product Development Engineer II
7 days ago
Galway, Ireland CareerWise Recruitment Full timeProduct Development Engineer II is required by CareerWise Recruitment for our Galway based client. You will participate as a team member in the Product Development process from concept to commercialization of novel Medical Devices. As Product Development Engineer you will act as a technical leader for projects and may be assigned engineers, technician,...
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R&D Technician II
7 days ago
Galway, Ireland Life Science Recruitment Ltd Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
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Quality Engineer II
1 week ago
Galway, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...
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Quality Engineer
7 days ago
Galway, Ireland CareerWise Recruitment Full timeA Quality Engineer is required by Careerwise recruitment to work with a Galway based electronic manufacturing company. THE ROLE: Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process...
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Quality Engineer
7 days ago
Galway, Ireland Collins McNicholas Full timeOur client, a leading multinational company based in Galway, is seeking to hire three Quality Engineers for an initial 12-month contract, with the potential to turn permanent. The Role: The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in moderately complex Quality related...
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Quality Engineer
7 days ago
Galway, Ireland Wallace Myers International Full timeMy client who are an exciting Galway based medical device start-up are seeking an experienced Quality Engineer to join their team. This position requires 3+ years' experience and a proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial...
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Galway, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...
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Cregg Recruitment | Senior R&D Manager II
4 weeks ago
Galway, Ireland Cregg Recruitment Full timeSenior R&D Manager II We are seeking aSenior R&D Manageron apermanent basisto join our world leading galway-based manufacturing client. This role reports to R&D Director. Excellent salary full benefits provided. To discuss please reach out with your CV to / Job Purpose Our Galway-based multinational medical device manufacturer is seeking a manager for an...
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Senior Quality Engineer
7 days ago
Galway, Ireland Life Science Recruitment Ltd Full timeSenior Quality Engineer Our client a medical device startup company is seeking a Senior Quality Engineer to join their team. Reporting to the Senior Quality Manager the Senior Quality Engineer will work across all stages of development, manufacture, and commercialisation. The candidate will support the Senior Quality Manager with maintaining the Quality...
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Principal Quality Engineer
7 days ago
Galway, Ireland Life Science Recruitment Ltd Full timePrincipal Quality Engineer Our client a high potential and well-funded startup company are seeking a Principal Quality Engineer to join their team. Reporting to the VP of Quality and Regulatory Affairs. The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development...
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Quality Engineer
6 days ago
Galway, Ireland Smart Reactors Service Limited Full timeQuality Engineer (R&D) Full Time Job Description Smart Reactors are currently seeking a Quality Engineer to join our team located in Parkmore, Galway, Ireland. About Smart Reactors Smart Reactors is headquartered in Galway, Ireland and is a trusted provider of medical device coating technologies. We provide solutions to reduce thromboembolic complications,...
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Senior Design Quality Engineer
4 weeks ago
Galway, Ireland CK Group Full timeSenior Design Quality Engineer Overview: CK QLS are recruiting a Senior Design Quality Engineer, to join our clients team for a 12-month project with potential extension. The role will be based in a hybrid setting in Galway, Ireland, with 3 days on-site work per week. The ideal candidate will have 5-8 years of experience in Quality Assurance for medical...
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Wallace Myers International | Quality Engineer
4 weeks ago
Galway, Ireland Wallace Myers International Full timeMy client who are an exciting Galway based medical device start-up are seeking an experienced Quality Engineer to join their team. This position requires 3+ years' experience and a proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial...
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R&D Technician
7 days ago
Galway, Ireland Life Science Recruitment Ltd Full timeJob title:R&D Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component...
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Senior Quality Engineer- Start-up
1 week ago
Galway, Ireland Wallace Myers International Full timePosition Title: Senior Quality Engineer Position Summary To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and quality objectives. Assure compliance to applicable regulations. Lead quality activities such as audits, procedure development, documentation review and define changes to controlled...
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Project Manager Contract
6 days ago
Galway, Ireland KMR Recruitment Full timeEmbark on an exciting journey as the Major Infrastructure Project Manager for this leading health service provider, where you'll lead the delivery of transformative healthcare infrastructure projects that will shape the future of patient care. In this dynamic contract role, you'll be at the forefront of shaping the healthcare campus, overseeing the...
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Galway, Ireland Stem Recruitment Partners Full timeSTEM Recruitment Partners are working with an established medical device R&D company, based in Galway, that is seeking an experienced Product Development EngineerI to join their operations. The company is renowned for developing and manufacturing braided catheters and medical tubing. About the Company Due to a recent expansion, a lot of their global R&D...
