Quality Engineer
4 hours ago
Quality 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, while promoting Cell Proliferation & Healing in the case of implant devices. The company offers a wide range of services from early coating selection to manufacturing process transfer, while supporting regulatory approval & commercialisation. Job Summary The Quality Engineer will support our R&D Department, playing a vital role in implementing quality systems and procedures in-line with ISO 13485 requirements. This position will collaborate closely with internal teams ensuring compliance and promoting a culture of quality across the organization. Key Responsibilities QMS Management-Responsible for the upgrade & improvements to the QMS system Quality Documentation: Draft and approve and manage quality documentation, including procedures, protocols, and reports and records, to ensure compliance with customer specifications and industry standards in a timely manner. Lab Support: Plan and perform lab bench testing/coating, conduct engineering and competitor evaluations. Plan, develop, coordinate, and execute study activities for new products and processes. Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met, fostering strong relationships and understanding of customer needs. Cross-Department Collaboration: Interface daily with other departments to promote quality awareness and integrate quality initiatives throughout the organisation. Internal Audits/CAPA -Coordinate audits and Corrective Action Request (CAPA, SCAR). Qualifications Third Level qualification in Engineering/ Quality/ Science A thorough working knowledge of quality systems(ISO 13485) is essential A working knowledge of Statistics, SPS, and ideally the use of Minitab. Preferable Auditing experience to the requirements of ISO 13485/ 21 CRF Part 820 Proven experience in leading quality improvement initiatives and managing projects. Experience 2+ years industry experience working in a regulated medical device/ manufacturing area. Good knowledge of FDA 21CFR820 and international regulatory requirements Experience with data analysis tools (e.g., Excel, Minitab) Familiarity with relevant regulatory and quality standards (e.g., GMP, ISO). Excellent problem-solving abilities and critical thinking skills. Strong written and verbal communication skills. Ability to work independently and as part of a team in a fast-paced environment. Good knowledge of statistical evaluation techniques Strong interpersonal skills and the ability to communicate well both verbally and in writing. Location and Travel On-site, Parkmore Galway Occasional travel may be required for conferences, collaboration, or fieldwork. Flexible work hours may be needed to meet project deadlines or accommodate time-sensitive experiments. Benefits of Working with Smart Reactors Competitive salary Performance bonus. Equal Opportunity: All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Quality Engineer
1 day 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
1 day 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
1 day 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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Senior Quality Engineer
1 day 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
2 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 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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Senior Design Quality Engineer
3 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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Quality Engineer II
2 days 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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Wallace Myers International | Quality Engineer
3 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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Senior Quality Engineer- Start-up
2 days 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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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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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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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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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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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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Design Assurance Engineer
4 hours ago
Galway, Ireland Cregg Recruitment Full timeDesign Assurance Engineer - Galway Our Galway based client are now recruiting for a Design Assurance Engineer to join their team. This role offers an excellent opportunity to work with a world leading Medical Devices company and great career progression opportunities. Purpose Demonstrates commitment to the Quality Policy (patient safety and product quality)...
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NPI Engineer I
3 days ago
Galway, Ireland Sterling Engineering Limited Full timeNPI Engineer Responsibilities• Duties / Accountabilities (incl. Deputation):• This involves but is not limited to:• Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved.• Planning, implementing and co-ordination of New Product Introductions to include:...
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Design Assurance Engineer II
2 days 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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Validation Engineer
4 hours ago
Galway, Ireland Cregg Recruitment Full timeValidation Engineer - Galway CREGG are now recruiting for Validation Engineer. This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway, working as a Validation Engineer on the latest projects and state of the art equipment. This role offers great working flexibility with great career progression opportunities. The role:...
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Manufacturing Engineer
1 day ago
Galway, Ireland Cregg Recruitment Full timeManufacturing Engineer - Galway About the role: Our Galway based client are now recruiting for a Manufacturing Engineer to join their team. This role offers an excellent opportunity to work with a thriving medical devices company with great career progression opportunities. The successful candidate will be responsible for providing daily support of products,...
