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    Junior Quantity Surveyor  

    - Ballina

    Junior Quantity Surveyor Reporting to: Lead Quantity Surveyor Location: Mayo Salary: €35,000 Position Overview Gi Group Recruitment is currently seeking a Junior Quantity Surveyor to support the commercial and project delivery teams within a dynamic engineering environment. The information below covers the role requirements, expected candidate experience, and accompanying qualifications. This role offers exposure to both project delivery and tendering activities across international markets. The successful candidate will assist in managing costs, mitigating risk, supporting procurement activities, and ensuring commercial performance across multiple live and prospective projects. Key Responsibilities Commercial & Project Support Work closely with Project Management and internal departments to deliver day-to-day quantity surveying functions on active projects. Monitor project performance and provide regular commercial reporting to management to safeguard profitability. Assist in the preparation and agreement of interim payment applications with clients. Prepare and negotiate project variations, ensuring all submissions are fully supported and commercially robust. Compile and agree final accounts upon project completion. Tendering & Pre-Construction Support the preparation and submission of competitive tenders for domestic and international projects. Review tender documentation thoroughly to ensure compliance with client specifications and highlight potential commercial risks. Contribute to cost planning to help secure successful project outcomes. Develop strong professional relationships with client-side commercial and project teams. Procurement & Cost Control Review and assess supplier and subcontractor quotations, confirming alignment with project quantities and specifications. Carry out material take-offs prior to issuing purchase requisitions and flag discrepancies where identified. Support cost optimisation strategies for materials and key project components. Assess subcontractor applications and invoices, ensuring contractual compliance before recommending payment. Project Controls & Compliance Identify and track changes between Approved for Construction (AFC) drawings and tender documentation. Maintain and update cost tracking databases and reporting templates. Ensure all work is completed in accordance with company QEHS standards, procedures, and documentation requirements. Contribute to company objectives relevant to the role and actively support quality, environmental, health and safety policies. Candidate Requirements Bachelor's Degree (or equivalent) in Quantity Surveying, Mechanical Engineering, or a related discipline. Previous exposure to HVAC or mechanical projects is desirable. Strong numerical and analytical ability. Detail-oriented with strong commercial awareness. Effective communication skills and ability to work collaboratively within project teams. KSGalway Should you require any support or assistance, please contact your local Gi Group office. Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Gold status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters. Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role. We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. xsokbrc To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website. Skills: CAD BIM Quantity Surveyor

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    Accountant  

    - Ballina

    FDC Group is a fast growing, full service, multi-disciplined professional services provider. The information below covers the role requirements, expected candidate experience, and accompanying qualifications. Established in 1973, with headquarters in Cork and 50+ office locations nationwide, we offer a range of Accounting, Auditing, Taxation, Agri-Consultancy, Financial and Business Advisory to a diversified portfolio of 30,000+ clients. We areseekingto hire a?Part-Qualified Accountant?in our?Claremorris, Co. Mayo?office. Responsibilities: Preparation of accounts Adhere to all compliance deadlines Input into andassistingwith the office work plan Management of multiple jobs ensuring the keyobjectivesare delivered asrequiredandin a timely manner Dealing with ad-hoc client queries Candidate Profile: Minimum 12 months practice experience within a general accounting team Proficient in the use of SAGE Accounts Production Proficient in the use ofBrightPayPayroll Package Experience of VAT, PAYE & CT returns. Experience in bookkeeping Good communicationand interpersonal skills Self-motivation and capability of working on your own initiative Strong organisational and time management skills Committed to obtaining a professional qualification FDC Benefits ACCA accredited? Opportunities for personal and professional growth with our internal training.? A supportive and inclusive work environment.? A charity fund and sustainability initiative.? Pension scheme.? Aviva Care which includes access to digital GP, second medical opinion, bereavement support, family care mental health support, life?assurance?and PHI cover.? Excellent?remuneration? xsokbrc packages? Skills: acca Accounting Accountant Benefits: Pension Fund Medical Aid / Health Care Group Life Assurance Funeral Plan

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    Engineering Director  

    - Ballina

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Find out if this opportunity is a good fit by reading all of the information that follows below. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description We are excited to invite applications to our site Engineering Director position here at AbbVie, Westport, Co. Mayo. Reporting to the Site Director, you will interact with the global engineering group and act as a key member of the site senior leadership team, delivering on our key strategic initiatives, influencing site financial growth and business decisions. The position leads the site engineering function across our aseptic fill-finish production facility (covering Aseptic manufacture of Biologic, Eyecare and Implant Drug Products). The role is accountable for delivering high performing process and utility equipment, ensuring a best-in-class compliant facility to meet the stringent demands of modern Aseptic Fill-Finish processing. In the role you will lead, guide and develop teams across Process Engineering, Maintenance, Aseptic Engineering, Capital Project Engineering, Environmental Sustainability, Site Security, Business Continuity Planning, Automation and Business Technology. It's a key position at our site and one that will offer you a defined career path. Did we tell you the role is based in Westport, one of the Wild Atlantic Way's most picturesque and family-friendly towns? So if this sounds like an interesting role then please read on and submit your application to start the conversation. Here is a snapshot of your responsibilities: Delivery of the required Safety, Environmental, Quality and Financial performance of the Engineering Department. Partnering with the Site Leadership Team, ensure that the Site meets its Safety, Environmental, Quality, Customer Service and Financial goals through the effective management of plant resources. Lead high performing cross-functional and/or matrix teams, creating a positive employee engagement culture aligned to the AbbVie Way. Accelerate the development of key talent. Build relationships across the organization. Contribute to the safety of our employees through provision of a safe workplace and showing leadership in the 'Zero, Believe It, Achieve It' Cultural Safety initiative. Ensure qualification status of all equipment is maintained and facilitate optimise equipment design and set-up from an Aseptic perspective. Drive top-tier equipment reliability through the AbbVie Maintenance Excellence Program. Deliver the approved Capital Investment plan, including all aspects of planning and execution. Ensure delivery of Engineering projects on time and within budget; Ensure alignment of Site Leadership Team on priority projects which deliver site and enterprise strategic imperatives. Develop and implement projects to support the introduction of New Products. Develop annual capital Long Range Plan (LRP) to support any investments required to maintain or increase capacity and capability. Lead the Business Continuity Plan for the site. Lead the Site Automation team, ensuring delivery of all objectives. Be the point of contact for Business Technology Systems (BTS), ensuring a strong partnership to deliver on site objectives. Lead Environmental Sustainability initiatives for the site including maintaining ISO 50001 Registration through strategic long range planning, project identification and execution, management of Energy Team, Quarterly Reviews, energy monitoring and analysis Developing and executing the site Environmental Sustainability Long Range Plan Lead the provision of Site Security services. Ensure maintenance and upkeep of site buildings, internal and external. Ensure contractor compliance with all relevant legislative and company requirements/procedures. Qualifications Education and Experience required: Bachelor's degree in Electrical, Mechanical or Chemical Engineering (Masters an advantage) 10+ years of Engineering and/ or Operations experience (Large Molecule, Small Molecule, Biologics, Parenteral, API, Drug Product, Finishing/Packaging) Demonstrated leadership, coaching, and mentoring of diverse teams Excellence in cGMP and regulatory environments relating to the regulated healthcare industry, project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. xsokbrc To start the process, click the Apply button below to Login/Register.

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    Relief Programme Facilitator  

    - Ballina

    We are an independent voluntary organisation providing services and support for people with disabilities and their families for more than 70 years. Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description. Our work positively impacts the lives of over 12,000 people with disabilities, equipping them with the confidence, skills, and self-belief to achieve their expressed goals We Welcome All Backgrounds and Abilities! We are an inclusive employer and encourage applicants from diverse backgrounds, including those with different abilities. We are committed to providing an inclusive and accessible work environment for all individuals. If you require any reasonable accommodations during the application process or once employed, please let us know. Examples of accommodations we can provide include modified workstations, flexible work hours, assistive technologies, or adjustments to communication methods during interviews or in the workplace. Our goal is to ensure that all candidates and employees have the support they need to succeed in their roles. We will work with you to meet your needs. Join Our Team and Make a Difference! Relief Programmes Facilitator 12-month Fixed Term Contract, variable hours per week Location: Castlebar Resource Centre, Castlebar, Mayo About the Role: To promote and support independent living and community integration. To facilitate in the educational, developmental, recreational and occupational programmes and activities of the service, as appropriate. Programmes will be designed to match the service user's needs and capabilities while allowing him/her to develop his/her full potential and will be implemented at an appropriate time and setting in order to give maximum support. What We're Looking For: 1-year minimum experience of working in a relevant Setting with the experience of facilitating and implementing person centred plans, experience in the design, development and provision of programmes and activities to meet the needs, choices and abilities of service users including providing support in the area of independent living skills and community integration for persons with intellectual disability. Experience of lone working. Experience of supporting people in the community in line with New Directions. Experience of recording keeping and use of IT to the required standard. Experience of supporting adults with Challenging Behaviour. Experience of supporting adults with Autism. A specific interest in services, activities and programmes to cater for the needs of persons with an intellectual disability and/or a dual diagnosis and behaviours that challenge. Experience of maintaining a focus on Health, Safety, Hygiene and good housekeeping guidelines in a service setting and ensuring best practice. Experience of promoting Self Advocacy with service users. Full driving license required. Flexible with regard to working hours in order to meet the operational needs of the service. Evening work may be required. Experience of delivering employment programmes and supporting service users with achieving work opportunities is desirable. At Rehab Group, we understand that there are many paths of learning to your chosen career. We know that standardised educational training is not a shared experience, particularly for people with differing abilities. If you meet the majority of the requirements for the position you are applying for, we are happy to discuss the role with you further. You might be exactly who we are looking for. Your Responsibilities: * A commitment to living the organisational values of Teamwork, Dignity, Justice, Advocacy and Quality. * To be a key worker to service users in order to facilitate the Person Centred Planning process. To identify goals and supports required by individual service users and maintain records as required. * To develop and deliver person centred programmes to meet the needs of service users as identified through Person Centred Planning and to maintain the required records. * To carry out daily duties such as health and safety checks, making telephone calls, updating records, canteen and general supervision, facilitating activities and programmes and any other reasonable duties as deemed appropriate by the Programmes Supervisor / Services Manager. * To Work as part of a team ensuring good communication within the team and with external agencies and families and maintaining the relevant records. * To observe all rules and regulations of the RehabCare services ensuring that all relevant Rehab Group administrative rules, regulations policies and procedures are adhered to at all times. * To promote and support independence and community integration in your approach with the service user group including liaising with key community-based personnel in pursuit of accessible community activities in accordance with the service user's choices and aspirations. * To comply with health and safety legislation and be proactive in maintaining highest standards of safety, hygiene and good housekeeping within the service. To ensure the safe transportation of clients when using transport, by adhering to the use of all safety equipment, as appropriate. * To comply with health and safety legislation and be proactive in maintaining highest standards of safety, hygiene and good housekeeping within the service. To ensure the safe transportation of clients while on transport, by adhering to the use of all safety equipment, as appropriate. Additional Requirements: * Full driving licence is essential. * Minimum QQI Level 5 in Social Care or equivalent. * A third level graduate, Health & Social Care or equivalent is desirable. * Additional qualification in supporting adults with Autism or Challenging Behaviour would be desirable. * Willingness to attend conferences / training courses when necessary. If applicable, candidates will need to provide a police certificate for any country they've lived in before moving to Ireland A panel may be formed as a result of this campaign. Salary at point 1 €32,566.03 pro rata, €16.06 per hour. What We Offer: * Company Pension Scheme * Paid maternity/paternity/adoption leave * Educational leave * 27 days annual leave * Bike to work scheme * Tax saver travel scheme * Income protection * Unpaid leave * Health and Wellbeing programme * Company credit union scheme * Employee discount scheme * Digital Doctor * Financial support for studying and study leave * Long Service Reward Scheme * Sick leave * Employee Assistance Programme (EAP) How to Apply: Submit your application by 27/02/2026 The recruitment process usually involves an initial application, screening, followed by interviews (often in-person or virtual) and possibly assessments related to the role. xsokbrc We may close applications early if we receive a high volume of suitable candidates. The Rehab Group is an equal opportunity employer

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    Project Quantity Surveyor - Mayo  

    - Ballina

    My client is a leading Tier 2 Building Contractor who have a proven track record of delivering high end residential and commercial projects across the West Of Ireland. If you think you are the right match for the following opportunity, apply after reading the complete description. Due to their ongoing success, they are seeking a Project Quantity Surveyor to join their team on a new residential Project in Mayo This is a good opportunity to work within a well-established team on a prestigious project. Their current workload is exciting and you will be involved at all stages of the project and as a member a member of this team, you will have the opportunity to develop and bring added value to the team where career progression is guaranteed. Responsibilities: Production of monthly Value Cost Reconciliation and Forecasting reports. Preparation and agreement of monthly project Payment Claims. Preparation of Internal and External Project Cashflow information. Change Control including change identification and negotiation. Identifying and quantifying the effects of Delay and Disruption on projects. Monitoring all ongoing commercial aspects during the course of the project. Liaising with Clients and Client Representatives. xsokbrc Administering the provisions of the Contract in respect to notifications. Procuring Subcontractors & Suppliers Compiling and Issuing Subcontracts Negotiating and agreeing Subcontractor final accounts Requirements: Minimum 4 years experience in a QS role Contractually and commercially astute Excellent written and spoken communication skills, dealing with clients and design teams Excellent Negotiator IT Literate Experience with Cubit, CostX & COINS software packages preferable Previous experience working on high quality medium and large-scale projects Valid Safe pass and Manual Handling certification desirable If you are interested in applying for this role, please click the link below Skills: Project Cost Control Cost Reporting Commercial Management Cost Planning Quantity Surveying

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    Process Engineering Lead - NPI  

    - Ballina

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Make sure to apply with all the requested information, as laid out in the job overview below. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Process Engineering lead - NPI will report to the Director of the Tech Center business unit and be responsible for the Site New Product Introduction Programs. This position has responsibility for providing direct oversight, management, and leadership with minimal technical or administrative guidance, as well as responsibility for all aspects of technical process support such as but not limited to project management, process monitoring and validation programs within the site. This includes leadership of in-line product support for processes, project definition and demonstration, and process improvements/productivity while assuring compliance with regulatory agencies. These activities involve economic feasibility studies toward objectives assigned or approved by site leadership. Main duties & responsibilities: Lead personnel (team of 7-9) responsible for New Product Introduction Programs of the site for Biologics. Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project. Provide technical guidance and continuous improvement support for commercial and new product introductions on day-to-day production and processing issues: problem solving, deviations, manufacturing documentation changes, etc. Source for plant consistency across the Division, share problem-solving activities, and maintain updated technical product history. Provide technical assistance with the implementation of changes in manufacturing equipment, batch size, ingredient supplier and experimental batches as needed. Ensure that products and processes are kept in compliance with validation requirements. Identify and solve technical problems independently for new products and for commercial operations. Plan data collection organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods. Evaluate new process equipment and advises management about areas of opportunity in the application of novel technologies. Implement at plant level global technical initiatives as: new technologies, suppliers, methods, etc. and provide tactical perspectives. Assure fulfilments of environmental, health, and safety (EH&S) requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Qualifications M.Sc. in a relevant Science area and extensive experience in a "hands on" Process Engineering or development for new product introduction position. Experience of managing and leading professional teams that include Engineers and or Scientist personnel. Experience leading product transfer and New Product Introduction projects. Regulatory filing experience as well as familiarity with HA audits. Excellent communication and interpersonal skills for interaction with both internal departments and other AbbVie sites worldwide (QA, Validation, IS, EHS, R&D, S&T). Computer literate with knowledge of statistical methods, data assimilation and interpretation. Capable to positively influence department employees and/or contributors from other disciplines or peers of higher managerial levels to obtain decision approvals for critical courses of action, either exception or planned. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. xsokbrc To start the process, click the Apply button below to Login/Register.

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    Civil Estimator, Mayo  

    - Ballina

    Design Build Search are working with a rapidly expanding civil contractor who continues to grow nationwide. Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. Our client now has an opening for a Senior Estimator in their Mayo office.The SeniorEstimator will play a critical role in securing high-value projects. This is a opportunity to work on impactful civil engineering projects while playing a key role in our continued growth. Projects: Water roadworks Telecommunications Whats expected: As a Senior Estimator, you will work with the BID manager and be responsible for all tendering process. As the Senior Estimator you will lead the preparation of accurate and competitive cost estimates for civil infrastructure projects, ensuring alignment with client specifications and industry standards. Key Responsibilities: Collaborate with the Bid Manager to ensure smooth and effective bid delivery. Develop detailed cost estimates for civil and utilities projects including water and wastewater infrastructure projects. Analyse drawings, specifications, and project requirements. Liaise with subcontractors and suppliers to obtain accurate pricing. Participate in risk analysis and value engineering sessions. Support pre-contract handovers and assist the delivery team with cost data. Maintain up-to-date knowledge of market trends, rates, and innovations in civil works. Support the Bid Manager with ongoing departmental improvements and initiatives. Qualifications & Experience: Proven track record in a similar estimating role. Strong working knowledge of civil engineering project delivery and tendering best practices. Demonstrated ability to contribute in a team environment and communicate clearly across stakeholders. A proactive problem-solver with a flexible, solutions-oriented mindset. Excellent communication and commercial acumen. xsokbrc Engineering or Quantity Surveying degree preferred. Skills: civil engineer Quantity Surveying civil estimator Construction Management finance manager

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    Company Description AbbVie's mission is to discover and deliver innovative therapies and solutions that address serious diseases today and the medical challenges of tomorrow. Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. We strive to make a remarkable impact on patients' lives across several key therapeutic areas: immunology, ophthalmology, oncology, neuroscience, and virology, as well as in aesthetic medicine with products and services from our Allergan Aesthetics portfolio. For more information about AbbVie, please visit: - Follow @abbvie on LinkedIn, X (formerly Twitter), Instagram, and YouTube. Job Description At AbbVie Westport, we are dedicated to improving lives through transformative medicines and innovative healthcare solutions. Our commitment to excellence is driven by our talented team, and we are thrilled to invite you to be a part of our journey. Every day at AbbVie counts, as we harness passion and dedication to positively impact health worldwide. When you join AbbVie Westport, your efforts will directly contribute to the betterment of human health across the globe. Our success is fueled by exceptional individuals with high-level technical capabilities and expertise, excelling in pioneering science and healthcare innovations. Working at AbbVie Westport As our business evolves through cutting-edge research, we are eager to engage with talented individuals ready to join us on our mission. We are currently hiring for Manufacturing Technicians Technical Shift Leads Technical Writers Interested in joining us on this exciting journey? Please register, so we can keep you in mind for these opportunities. Join us at AbbVie Westport, where your expertise and passion will help us make a meaningful impact on healthcare, both locally and globally. Additional Information Whatever your area of expertise-medical, regulatory, market access, human resources, legal, marketing, communications-you'll find exciting challenges and opportunities to explore new career paths at AbbVie. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: To be considered for this role you will be redirected to and must complete the application process on our careers page. xsokbrc To start the process, click the Apply button below to Login/Register.

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    Quantity Surveyor  

    - Ballina

    Quantity Surveyor Civil Engineering Contractor (Cloghvoley, Kilkelly, Co. Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Mayo) Permanent | Full-time | Competitive Package A long-established and respected civil engineering, quarrying, asphalt, and contracting organisation in the West of Ireland is seeking a Quantity Surveyor for its operations based in Cloghvoley, Kilkelly, Co. Mayo. This role is ideal for a QS who wants to join a stable, multi-disciplinary contractor delivering roads, utilities, heavy civils, surfacing, aggregates, and regional infrastructure projects. Key Responsibilities Manage the commercial and contractual requirements of civil engineering projects from tender stage through to final account. Measure works, prepare BOQs, and assist with cost planning and tender submissions. Handle valuations, variations, claims, and prepare detailed cost reports. Monitor project budgets, control spend, and report on profitability. Liaise with project managers, site teams, clients, subcontractors, and suppliers. Prepare and negotiate subcontract packages and manage subcontractor accounts. Ensure compliance with contracts and company procedures. Support forecasting, risk management, and cost-saving initiatives. Experience & Skills Required Degree-qualified Quantity Surveyor (or equivalent construction/commercial qualification). 2+ years experience in civil engineering, roadworks, utilities, quarrying, surfacing, or general contracting. Strong measurement skills with experience in cost control and commercial reporting. Ability to work independently and communicate effectively with internal and external stakeholders. Excellent analytical, negotiation, and organisational skills. Whats on Offer Competitive salary based on experience. Long-term career progression within a major West of Ireland contractor. Exposure to varied and challenging civil and infrastructure projects. Supportive, secure, and well-established working environment. xsokbrc Head office role. 8am 4.30pm Monday to Friday

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    Senior Quality Engineer  

    - Ballina

    Senior Quality Engineer 12 month Fixed Term contract Job Summary: We are seeking a proactive and detail-orientedQuality Compliance Engineerto join our Quality Assurance team for a12 month contact. Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, includingISO and the fully implementedEU MDR. Your responsibilities will include completion of end-to-endvalidation lifecycle (IQ/OQ/PQ), performing rigorousrisk assessments (pFMEAs), and supporting thechange control processto maintain product integrity. In addition, you will be a primaryQuality Liaisonfor the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection. Key Responsibilities: Product and Process Validation:Develop, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes to ensure high-degree assurance of product requirements. Risk Management:Lead and maintain risk management files, including pFMEAs ensuring that all potential failure modes are identified and mitigated. Production Quality Support:Provide real-time QA support to the operations team to address non-conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions). Audit Readiness:Support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements. Statistical Analysis:Apply statistical techniques and tools (e.g., Minitab) to analyze process data, identify trends, and support data-driven decision-making for process improvements. Other duties as assigned Qualifications: Required: Bachelors degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences. 5+ years of experience in quality assurance or Validation in the medical device or a similarly regulated industry. Solid understanding of ISO 13485, EU MDR, ISO 14971 and relevant medical device regulations. Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Excellent written and verbal communication skills, especially in technical writing and documentation. Proficient in data analysis tools such as Excel, Minitab, Power BI or similar. Preferred: Certified Quality Engineer (ASQ CQE) or similar professional certification. Certified Internal or Lead Auditor Knowledge of EU MDR and international medical device regulations. Six Sigma or Lean Certification is a plus. Competencies: Strong attention to detail and commitment to quality. Ability to manage multiple tasks and projects in a fast-paced environment. Collaborative mindset with ability to work effectively across departments. xsokbrc Self-motivated with a continuous improvement mindset.



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