Our client is seeking a skilled Senior Software Quality Engineer to join their team. This role offers an exciting opportunity to contribute to a global medical device organization, ensuring the highest standards of quality and compliance in computerized systems. Responsibilities: Develop and review validation documentation in line with regulatory requirements and internal quality policies, ensuring a strong understanding of the Quality Assurance role. Conduct Software Compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet industry standards and regulatory requirements, including familiarity with 21 CFR 820 and ISO 13485 regulations. Maintain and continuously improve the quality and compliance status of associated procedures and work instructions, ensuring high attention to detail and accuracy in all deliverables. Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives, demonstrating effective time management and organizational skills. Support audits and regulatory inspections by providing validation documentation and quality assurance insights, ensuring a smooth process during audits and inspections. Collaborate effectively with cross-functional teams, guiding them on validation tasks and ensuring alignment with best practices, while demonstrating strong interpersonal and conflict resolution skills. Handle software change management tasks, ensuring that changes comply with regulatory requirements and internal quality standards. Work as an individual contributor, without direct reports, yet maintaining strong teamwork skills and contributing to a positive, collaborative environment. Qualifications & Experience: A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred. Hands-on experience with computer system validation deliverables. Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered. Knowledge of software change management and regulatory compliance standards. Benefits: Family health insurance Excellent pension scheme Life assurance Career development opportunities State-of-the-art facility Growing business with access to additional benefits For a confidential discussionandmore information on the role,please contactKevin Griffin Skills: Validation Change Management Software Validation
Are you an experiencedLine Support Technicianwith a background inmedical device manufacturing? This is an exciting opportunity to join a leading organisation in Galway, where you'll play a crucial role inoptimising production line performance, ensuring high-quality standards, and driving process improvements. As a key part of theOperations team, you'll have ahands-on presence on the production line, working closely with operators to maintain efficiency, prevent deviations, and support continuous improvement initiatives. Key Responsibilities: Optimise production performanceby closely monitoring workstations and proactively addressing any process deviations. Drive continuous improvement(Kaizen mindset) by refining workflow sequences for better efficiency and output. Support operator training and upskilling, ensuring all team members follow best practices and achieve high-quality standards. Conduct workstation audits, reviewing reject units and compliance with manufacturing guidelines. Investigate and report downtime issues, implementing corrective actions to minimise disruptions. Collaborate with cross-functional teams, including Engineering and Quality, to support new product introductions and process enhancements. Maintain compliancewith allGMP, safety, and regulatory standardsin a cleanroom environment. Represent the production teamin KPI update meetings, providing insights into performance and improvement opportunities. Key Requirements: Previous experience in medical device manufacturing(cleanroom environment is essential). Strong technical knowledgeofPOBA catheters and stents. Proficiency in multiple workstation tasks andhands-on production support experience. Good working knowledge of Microsoft Office(Word, PowerPoint, Excel). Strong communication, organisational, and problem-solving skills, with a proactive mindset. Why Join? This company offers acompetitive benefits package, including: Healthcare & Dental Cover Pension Contributions & Life Assurance Paid Maternity & Paternity Leave Employee Recognition & Assistance Programmes Learning & Development Support On-site Canteen & Corporate Discounts Sports & Social Club, Wellbeing Events & Bike to Work Scheme For a confidential discussion on the role and the organisation please contact Emma Barry today. Skills: Cleanroom Production GMP
Our client a Global Pharmaceutical Manufacturer in Mayo are seeking a highly skilled and motivated Digital Transformation Architect and Project Manager to lead and drive digital initiatives at their biopharmaceutical site. This role will be pivotal in designing and implementing innovative digital solutions that enhance operational efficiency, improve data management, and support the overall strategic goals of their organization in phase with their Future factory group initiatives. The ideal candidate will possess a deep understanding of digital technologies, project management methodologies, and the biopharmaceutical industry. 12 month contract | Fully on-site Key Responsibilities: Digital Strategy Development: Collaborate with senior leadership to define and articulate the digital transformation strategy aligned with the company's vision and goals. Assess current processes and technologies to identify opportunities for digital enhancement. Architectural Design: Design scalable and robust digital architectures that integrate emerging technologies such as data analytics, artificial intelligence, IoT, and cloud computing into existing systems. Create detailed architectural documentation, including system designs, data flows, and integration strategies. Project Management: Plan, execute, and oversee digital transformation projects from initiation to completion, ensuring they are delivered on time, within scope, and within budget. Utilize project management methodologies (Agile, Scrum, etc.) to manage project timelines, resources, and deliverables effectively. Stakeholder Engagement: Collaborate with cross-functional teams, including IT, operations, regulatory affairs, and quality assurance, to gather requirements and ensure alignment on project goals. Communicate project status, risks, and milestones to stakeholders at various levels. Change Management: Develop and implement change management strategies to facilitate the adoption of new technologies and processes within the organization. Provide training and support to end-users to ensure successful implementation and utilization of digital tools. Performance Measurement: Establish key performance indicators (KPIs) to measure the success and impact of digital transformation initiatives. Conduct regular reviews and assessments to ensure continuous improvement and alignment with business objectives. Regulatory Compliance: Ensure all digital initiatives comply with industry regulations and standards, including FDA, EMA, and GxP guidelines. Qualifications: Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field; a Master’s degree is preferred. Minimum of 5 years of experience in digital transformation and project management within the biopharmaceutical or related industry. Strong knowledge of digital technologies, data analytics, and software development methodologies. Proven experience managing complex projects with multiple stakeholders and cross-functional teams. Excellent communication, leadership, and interpersonal skills. Strong problem-solving skills and the ability to think strategically. For a confidential discussion and more information on the role, please contact Emma Daly. Skills: Digital Strategy Development Project Management Architectural Design #J-18808-Ljbffr
Collins McNicholas Sligo, County Sligo, Ireland 4 days ago Be among the first 25 applicants Principal Consultant - Specialist in Commercial, Finance, Supply Chain, Customer Service, Multilingual - Galway - +353 91 706712 The HRBP will be flexible, professional, approachable, sharp mindset, organised, and have an excellent work ethic. Within this role you will get to immerse yourself in all facets of HR operations. From policy advisory and employee relations management to HR systems maintenance and learning and development, you'll play a vital role in supporting the team's expertise. Responsibilities: Act as trusted consultant to managers on all employee relations, grievance and disciplinary issues by providing a professional and credible HR service. Provide HR advice to Line Managers and employees throughout all stages of the employee life cycle, ensuring advice is legally compliant and in line with company policy & procedure. Respond to internal and external HR related enquiries or requests and provide assistance. Support employee relations and internal communications activities. Alignment and implementation of policies and procedures across the organisation. Implementation, maintenance and effectiveness of the HR Information System across the organisation. Extraction and analysis of data from the HR Information system as required. Undertake projects relating to a range of HR disciplines as assigned by the Group Director of Human Resources. Work closely with the recruitment team to support the achievement of our talent acquisition plans nationwide. Assist in the design and delivery of internal training and development of colleagues. Liaise with payroll as required. Produce accurate and professional correspondence, policy documents etc. as required. Maintain HR record systems to ensure all employment requirements are met. Deputise for the Group Director of Human Resources as required. Requirements: Hold a third level qualification in a relevant area such as Human Resource Management, Business or Law. A minimum of 3 years' working experience in a similar HR Generalist or HR Business Partner role within the past 5 years. Strong demonstrable understanding of current and imminent Irish Employment Law. Experience of management and maintenance of Human Resource Information Systems. Highly IT competent in all aspects of Microsoft 365. Membership of the Chartered Institute of Personnel & Development. Experience of working in health or social care. At least six months in a supervisory role. Seniority level Mid-Senior level Employment type Full-time Job function Management, Human Resources, and Other Industries Nursing Homes and Residential Care Facilities, Hospitals and Health Care. #J-18808-Ljbffr
Are you an experienced Maximo System Administrator looking for an exciting opportunity in a leading construction and materials group? Our client is seeking a dedicated professional to manage, support, and optimize their IBM Maximo system. This is a hybrid role based in Westmeath with occasional travel to UK and NI sites. As a Maximo System Administrator, you will: User Management Set up accounts, roles, and permissions to ensure secure and efficient access. System Support Act as the first point of escalation for Maximo-related issues, providing Level 0 support. Data Integrity Monitor system data to ensure compliance with company policies and security standards. Reporting & Troubleshooting Manage scheduled reports and resolve technical issues in collaboration with internal teams and vendors. Training & Documentation Provide training and user support to maximize system adoption and efficiency. Change Management Log issues, handle change requests, and coordinate system updates. Ideal Experience of Maximo Administrator: Experience in Maximo administration, asset management, or enterprise system support. Technical knowledge of Maximo architecture, database management, and integrations. Problem-solving skills with the ability to troubleshoot and perform root-cause analysis. Security awareness to ensure compliance with security and data protection protocols. Project management experience with system upgrades, migrations, or implementations. Strong communication skills ability to work cross-functionally with teams across different locations. Proficiency in Microsoft 365 (Excel, Word, Outlook). Relevant degree (Business, IT, Computer Science) or equivalent work experience. Excellent Culture and Benefits: 25 Days Annual Leave + Bank Holidays Contributory Pension Scheme Career Development & Training "Make a Difference" Volunteering Day Bike-to-Work Scheme On-site Gym & Wellbeing Facilities Share Save Scheme For more information or a confidential discussion about thisMaximo system administratorrole, please contactMichelle Mileyator via email at Skills: Maximo Systems Administrator database management Project management
Accounts Assistant | Administrator required with 3 years plus experience in overall finance and payroll.Stand alone role reporting to MD.Co Galway. Responsibilities: Accounts Payable : account reconciliation and paying suppliers on time within credit limits Liaising with suppliers following up on credit notes/refunds etc Filing VAT Liaising with ROS /Revenue Liaising with the company accountant as required Bank Reconciliation monthly Answering customer queries regarding invoices/statements and/or payments Updating the debtors/ creditors and providing reports to MD Credit card reconciliation Processing invoices and statements and sending out to customers on the 1st of each month. Following up with customers on overdue debtor accounts Daily lodgements and cash flow management Payroll processing on weekly basis (8 10 employees). Goods receive notes entering / keeping stock accurate on system. Ad-hoc duties within the accounts realm (accounting reports, cost cutting initiatives etc.) Key requirements: Accounting Technician qualification would be an advantage. 3 years plus experience in account administration, payroll processing etc. Strong Excel skills. Experience in Intact/ SAGE or QuickBooks an advantage. Excellent communication skills and strong attention to detail is required. Ability to multitask, prioritise tasks and excellent organisational skills For a confidential discussion and more information on the role, please contactNoeleen Stewart. ?Loughrea, Oranmore, Athenry, Gort, Ballinasloe, Galway Skills: Accounts Assistant Accounting Technician Accounts Manager
General Manager - Permanent - Galway The General Manager will report to the business director. This person should have multi-faceted experience in overseeing business customer-facing operations as well as human resource, finance, and communication experience. The ideal candidate should be an expert communicator with a strong ability to delegate responsibility and collaborate across a range of departments. Ultimately, the General Manager should be driven by a desire to lead our business to maximum profitability and efficiency. Responsibilities: In association with business directors, develop a strategic plan for continued profitability and growth. Review and improve organisational effectiveness by developing processes, overseeing employees, maintaining a highly motivated work environment, and implementing innovative changes. Adhere to company standards in excellence and quality of service levels. Seek out opportunities for expansion and growth by developing new business relationships. Provide guidance and feedback to help team members strengthen specific knowledge and skill areas. Oversee day-to-day operations of all departments in association with department leads, ensuring profitable and efficient operation of same. Recruit, onboard, and train high-performing employees to achieve objectives for sales, profitability, and market share. Maintain project timelines to ensure tasks are accomplished effectively. Develop, implement, and maintain budgetary and resource allocation plans. Delegate responsibilities to the best-qualified employees and ensure all policies, procedures, standards, specifications, guidelines, training programs, and company values are maintained. Resolve internal staff conflicts efficiently and to the mutual benefit of all involved. Required Skills and Qualifications: Proven success in a managerial role. Strong decision-making ability. Excellent communication, collaboration, and delegation skills. Proven ability to develop and achieve financial plans. Ability to motivate and lead employees, and hold them accountable. Strong working knowledge of operational procedures. Bachelor’s degree (or equivalent) in business management or related field. Experience in conducting performance evaluations. Working knowledge of human resources processes. For a confidential discussion and more information on the role, please contact Deirdre Moran. #J-18808-Ljbffr
Our 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 projects. Responsibilities Possesses and applies a broad and increasing knowledge of Quality, and its application to complete moderately complex assignments. Broad knowledge of operations and practices to enable informed decisions in day-to-day operations and assignments. Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/incomplete information. Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances. Drives business improvements through continuous improvement initiatives. Acts as an escalation point for quality-related non-conformances and CAPAs. Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. Requirements Third level qualification. Minimum 5 years of experience in the medical device industry with a minimum of 3 years in progressively responsible positions. Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP). Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL). Broad knowledge of engineering and technical applications applied in the development of medical devices is useful. Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded decisions regarding conformity during audits. Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time. Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets. For more information and a confidential discussion on the role please contact Michelle Mc Inerney. Skills: Quality Engineer, CAPA #J-18808-Ljbffr
Our client a major multinational based in Galway is looking to hire a Regulatory Affairs Specialist on a 12-month fixed-term contract. The Role: As the Regulatory Affairs Specialist, you will assist in managing and developing the activities of the EU Authorised Representative (AR) and the UK Responsible Person (RP) in line with established procedures and processes. You will provide support to the designated Person Responsible for Regulatory Compliance (PRRC), ensuring proper oversight of activities and implementing any necessary updates through the Quality Management System. Additionally, you will assist the designated UK Responsible Person(s) in maintaining oversight of activities and ensuring timely updates are carried out. Responsibilities: Carries out duties in compliance with established business policies and procedures. Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, MHRA, HPRA and other regulatory agencies. Support the assessment of the regulatory status of products with regards to applicable regulations, including EU MDR / IVDR and UK and Switzerland MD and IVD regulations. Prepares for and assists with quality audits - internal and external, as required. Update company and external databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e. EUDAMED etc. Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job. Perform other duties and projects as assigned. Act as an initial and ongoing point of contact for customer sites and external regulators and others for AR and UK RP related requests. Collate electronic and paper documents to allow the registration or removal of products according to procedures. Review and update external databases to ensure that information related to products and manufacturers is correctly assigned. Administer and deliver requests for documents such as Certificates of Free Sale from Competent Authorities as required. Forward documents from the manufacture, AR, UK RP or Competent Authority, as required. Review and administer documents related to all types of regulatory, AR and UK RP activities. Communicate any complaints or potential complaints to the PRRC, Customer site and company complaint handling systems as required. Process Purchase Order Requisition numbers and submit invoices to Accounts Payable as required. Requirements: Experience of AR activities previously is desirable but not essential. Experience in medical devices or IVD regulation or regulatory activities is desirable but not essential. Bachelor’s Degree in a related field is desirable but not essential. High Proficiency in MS Office software. Flexibility to travel as required. Occasional out of hours working required to interact with sites on different time zones. Excellent administrative, organisational and business support skills, with the ability to multi-task and to work calmly under pressure. Excellent communication skills (written & verbal across cultures). Ability to coordinate meetings (by phone, video conference and face to face) to drive results and build relationships. Demonstrated administrative, written and verbal communication, negotiation and influencing skills. A track record of supporting multifunctional teams. Organised, detail-oriented, with a high level of confidentiality, and ability to work under pressure with changing priorities and deadlines. Ability to be resourceful and proactive when issues arise. Excellent organizational skills. Multitasking and time-management skills, with the ability to prioritize tasks. For more information and a confidential discussion on the role please contact Michelle Mc Inerney. Skills: Regulatory Affairs Specialist #J-18808-Ljbffr
We are working alongside a leading manufacturing company based in Co. Offaly to hire an Engineering Supervisor to join their team. The Engineering Supervisor will oversee maintenance, troubleshooting, and preventative Maintenance for all production machinery and plant equipment. Job Responsibilities: Support new equipment development, installation, and commissioning. Ensure optimal functioning of plant services (air, water, HVAC, plumbing, etc.). Apply strong electrical diagnostic skills to maintain and improve operations. Monitor production equipment performance and identify improvement opportunities. Conduct functional evaluations on new and non-standard components. Provide expertise in process and product improvements, including blueprint modifications. Maintain high standards of housekeeping, safety, and compliance. Train and develop staff to align with business needs. Work cross-functionally with all departments to drive efficiency and excellence. Job Requirements: Third Level Degree in relevant Engineering Discipline. Minimum 3 Years Experience in a Supervisor/Team Lead Role within a Manufacturing Environment. Strong understanding of quality assurance (Q.A.) procedures. Proven leadership experience or strong supervisory potential. Excellent problem-solving skills with a proactive approach. Strong commitment to health & safety standards. If you would like more information on this role you can contact Paul Dunican Skills: Engineering Supervisor Engineering Team Lead Maintenance Supervisor Maintenance Team Lead
