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Quasar Medical Medical Device Manufacturer
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  • Job Summary This role is based in our Galway, Ireland site and the candidate will be responsible for the EU and North American region, encompassing sites in Galway, Tecate, and the US. The successful candidate will serve as the regional owner of IFS ERP, leading implementation projects, managing system health, and acting as the key liaison between local business stakeholders and the Global IT team. Beyond IFS, the role oversees all IT systems and services across the region. Some travel may be required. Essential Job Duties and Responsibilities IFS ERP — Implementation & Support (Primary Focus) Lead and manage IFS ERP implementation projects across EU and NA sites, including scoping, design, configuration, testing, go‑live, and hypercare. Serve as the regional Subject Matter Expert (SME) for IFS ERP, providing guidance to business process owners across manufacturing, supply chain, maintenance, finance, and HR modules. Own the full IFS ERP lifecycle across the region — from system optimisation, incident resolution, upgrades, and integrations with other enterprise systems (e.g., MES/WMS/HCM), to master data governance, end‑user training, and QMS‑compliant documentation. IT Operations & Service Delivery Lead regional IT operations and service delivery across EU/NA sites, driving execution of the Global IT strategy. Identify technology gaps and initiate improvement initiatives in partnership with business and technology stakeholders. Coordinate IT emergency response, cyber‑incident management, and regional audit and regulatory activities. Develop and maintain IT policies, SOPs, and governance documentation to ensure compliance and operational consistency. Manage and develop regional IT staff and service providers while serving as the IT representative to site and regional leadership. Other Perform other assignments as directed by senior management. Education and Experience Requirements IT‑related degree or relevant qualifications from a recognised tertiary institution. 10–15 years’ IT experience, with a minimum of 10 years in hands‑on IFS roles. Proven end‑to‑end IFS implementation experience across at least one full project lifecycle, from requirements gathering to go‑live. Proven end‑to‑end IFS implementation experience across at least one full project lifecycle, with deep functional knowledge of IFS Cloud or Apps 9/10 across modules including Manufacturing, Supply Chain, MRO, Finance, or Projects. Hands‑on IFS configuration for complex manufacturing environments (BOMs, work orders, inventory, shop floor) with the ability to troubleshoot issues and integrate IFS with third‑party systems such as MES, WMS, LIMS, and BI tools. Experience with IFS data migration, security model, user role design, and access management best practices. Cloud and hybrid infrastructure management across Azure, AAD, InTune, and M365, with broader End‑User Computing and Workplace IT support. Cyber‑security policy, operations, and incident response, with proficiency across the Microsoft 365 suite including Teams, SharePoint Online, and Power BI. Other Strong stakeholder management and vendor management skills. Experience supporting manufacturing environments with ~500 employees strongly preferred. Experience in regulated industries (medical devices, pharma, or similar) is advantageous. Key Competencies Strong project and time management skills, with a proven track record of delivering complex ERP projects on time and to quality. Able to thrive in a dynamic environment, driving technology‑led change with clear communication to both technical and non‑technical stakeholders. Analytical mindset with the ability to translate complex business processes into effective system solutions and configurations. Committed to continuously developing IFS and broader IT skills to support business growth. Occasional business travel to regional sites is expected. Working Conditions and Physical Demands While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees. The employee is regularly required to stand and walk. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. On‑site role in an office environment, based at Quasar’s Galway, Ireland site with periodic travel to EU and NA regional sites. #J-18808-Ljbffr

  • Job Description Job Title: Quality Technician Location: Ballybrit Upper Industrial Estate, Monivea Rd Galway H91 XP49 Reports to: Senior Quality Engineer Job Summary The Quality Technician has responsibility for the effectiveness of assigned areas of the company’s quality system. Provides support to the operations function and incoming. Maintain records in accordance with the quality system requirements, which show that products manufactured by Quasar meet the requirements of end users, customers, regulatory authorities and the company. Maintain assigned areas of the Quasar Medical quality system in accordance with the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations (if applicable). The working week is a 4‑day week from Monday‑Thursday 7am‑5.15pm on‑site in a cleanroom and controlled manufacturing environment. This is initially a full time 12 month fixed term contract. Essential Job Duties and Responsibilities General Duties Provides support to Manufacturing and Product Engineering and Quality Engineers for commercial/validation projects. Supports implementation and maintenance of manufacturing methods, processes and operations for new and existing products. Supports dispositions of nonconforming material and processes. Supports sustaining Engineering and QE in resolving Manufacturing issues in the plant. Participate in lean and cost reduction activities. Supports the conduct of investigations and associated actions related to CAPA and Internal/external audit activities. Supports investigations and associated actions related to customer complaints. May assist designated auditors in the performance of site internal audits. May support execution/hosting of external audits. Supports maintenance of Quality System implementation. Specific Duties and Responsibilities Review batch records and approve release of product. Provide accurate Certificates of Conformance and/or Certificates of Analysis. Effectively communicate with other staff, customers and suppliers in order to promote quality awareness and to conform to customer requirements. Identify areas for improvement and lead improvement initiatives. Provide continued support for CER operations. Investigate, troubleshoot and report on system failures and product defects. Champion a structured approach to problem solving within process improvement teams. Investigate product returned from customers or product under non‑conformance. Complete investigation reports. Maintain control of documentation relating to the Site Production Department. Conduct Incoming Inspections as and when required on specific materials. Other duties may be assigned as the person matures within the position. Education and Experience Requirements It is desirable that the Quality Technician should have a good level of education with strong experience in a Medical Device industry and working within Controlled Environments. Experience in medical device is essential, two (2) to five (5) years. Good interpersonal skills and have the ability to multi‑task. Must be motivated and demonstrate the ability to be a self‑starter. Excellent communication skills with ability to interface at all levels. Should have strong analytical, organizational and influencing skills. Excellent computer skills. Preferred Skills and Abilities Experience with ERP systems (e.g., IFS, SAP, Oracle). Familiarity with advanced manufacturing technologies. Strong interpersonal skills – holding team accountable, emotional intelligence. Self‑starter with strong organizational skills and high degree of accuracy and detail. Excellent interpersonal and communication skills with the ability to work effectively with all levels of employees, suppliers, and customers. Ability to influence, negotiate and drive changes. Basic understanding of various balloon catheter manufacturing methods Basic knowledge of Lean Manufacturing environment Knowledge of basic problem solving skills, such as DMAIC and PDCA Other skills that may be required or learned on the job MS Office suite & MS Project Minitab Working knowledge associated with Knowledge of ISO13485 requirements GMP & FDA 21CFR:820 requirements Controlled environment per ISO 14644‑X ISO 14971 QMS Auditor Equal Opportunity Statement Quasar Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, colour, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre‑employment drug screening and background/criminal check, consistent with applicable laws. #J-18808-Ljbffr

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