Quality systems Engineer

3 days ago


Galway, Ireland Smart Reactors Service Limited Full time

Quality Systems Engineer (R&D) Full Time Job Description Smart Reactors are currently seeking a Quality Systems 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 systems Engineer will support our R&D Department, playing a vital role in managing & implementing ISO 13485 quality systems. 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 coordination, upgrade & maintenance to the ISO13485 QMS system Quality Documentation: Manage quality documentation, including procedures, protocols, and reports and records, to ensure compliance with customer specifications and industry standards in a timely manner. 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). Lab Support: Support lab bench testing/coating, conduct engineering and competitor evaluations. Plan, develop, coordinate, and execute study activities for new products and processes. 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. Contact: Skills: Quality systems Engineer Engineer Quality Systems


  • Quality Engineer

    2 weeks ago


    Galway, Ireland Life Science Recruitment Ltd Full time

    Job title: Quality Engineer Location:Galway Business Park, Dangan Benefits:Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and...

  • Quality Engineer

    3 days ago


    Galway, Ireland Life Science Recruitment Ltd Full time

    Job title: Quality Engineer Location:Galway Business Park, Dangan Benefits:Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and...

  • Systems Engineer

    5 days ago


    Galway, Ireland SPEEDECK Full time

    Mbryonics is at the forefront of free space optical communications. Our product portfolio covers a wide range of emerging technologies from photonic integrated circuits to advanced optical systems and embedded software solutions. Our optical communications systems are integrated and deployed in satellite communications systems. Our work is exciting and...

  • Quality Engineer

    24 hours ago


    Galway, Ireland Abbott Laboratories Full time

    About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities...

  • Quality Engineer

    2 weeks ago


    Galway, Ireland Cregg Recruitment Full time

    CREGGare seeking a proactive and skilled Quality Engineer to join a dynamic team at a leading wellness solutions company based in Athenry. Reporting to the Quality Manager, you will be part of an expanding team that plays a key role in improving processes, ensuring compliance with industry standards, and driving continuous improvements. Key Responsibilities...

  • Quality Engineer

    3 days ago


    Galway, Ireland Cregg Recruitment Full time

    CREGGare seeking a proactive and skilled Quality Engineer to join a dynamic team at a leading wellness solutions company based in Athenry. Reporting to the Quality Manager, you will be part of an expanding team that plays a key role in improving processes, ensuring compliance with industry standards, and driving continuous improvements. Key Responsibilities...

  • Quality Engineer

    2 weeks ago


    Galway, Ireland CareerWise Recruitment Full time

    A 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...

  • Quality Engineer

    3 days ago


    Galway, Ireland CareerWise Recruitment Full time

    A 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...

  • Quality Engineer

    2 weeks ago


    Galway, Ireland Wallace Myers International Full time

    My client, an exciting Galway-based medical device start-up, is seeking an experienced Quality Engineer to join our 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...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Principal 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...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Principal 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...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Senior 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...

  • Systems Engineer

    2 weeks ago


    Galway, Ireland E-Frontiers Full time

    Systems Engineer (Routing) 12 month contract Galway - hybrid (1 week a month in office) €300-350 per day Role Overview: This is the Routing Systems Engineer role. Need strong Genesys experience. Responsibilities: Proven background in software development, software quality engineering, agile (SCRUM), test-driven development, continuous integration, and...


  • Galway, Ireland CPL Full time

    Quality Engineer My client, a well-established manufacturer of health and wellness products is looking to recruit a Quality Engineer for their European headquarters located in county Galway. This position will report directly to the Quality Manager. Responsibilities: - Implement lean practices in QMS area. - Drive system improvement initiatives...

  • Quality Engineer II

    3 days ago


    Galway, Ireland Collins McNicholas Full time

    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...


  • Galway, Ireland Life Science Recruitment Full time

    We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties - Provides QA technical and compliance support for products and manufacturing related to suppliers,...

  • Engineer III

    2 weeks ago


    Galway, Ireland Rent The Runway Full time

    Founded in 2009, Rent the Runway is disrupting the trillion-dollar fashion industry and changing the way women get dressed through the Closet in the Cloud, the world’s first and largest shared designer closet. RTR’s mission has remained the same since its founding: powering women to feel their best every day. Through RTR, customers can subscribe, rent...


  • Galway, Ireland Cisco Systems, Inc. Full time

    Area of Interest: Cloud and Data Center Job Type: Professional Job Id: 1430710 About Cisco Global Demo Engineering: The Cisco Global Demo Engineering (GDE) team’s primary directive is to help our sellers and partners accelerate their sales by providing Customers, Partners, and Cisco Employees with a way to Experience Cisco Solutions. By demonstrating...

  • Systems Engineer

    2 weeks ago


    Galway, Ireland E-Frontiers Full time

    Systems Engineer/Platform Engineer Galway - hybrid (1 week a month in office) Contract: 12 months Day rate: 350 per day This is a Platform Engineering focused role requiring strong Genesys Engage and Linux experience. Responsibilities: - Provision new services/technologies, providing cost-effective telecommunications systems and technology...


  • Galway, Ireland Cpl Healthcare Full time

    Quality Engineer My client, a well-established manufacturer of health and wellness products, is looking to recruit a Quality Engineer for their European headquarters located in County Galway. This position will report directly to the Quality Manager. Responsibilities: 1. Implement lean practices in QMS area. 2. Drive system improvement initiatives...