<h1 data-start="154" data-end="213">Quality Assurance Lead &ndash; ERP Implementation Project</h1><h2 data-start="215" data-end="235">Description</h2>A highly experienced and detail-oriented Quality Assurance Lead is required for an ERP Implementation Project. This role involves leading the quality and compliance aspects of an SAP Cloud ERP transformation. It is a critical position for ensuring GxP compliance, data integrity, and operational excellence across regulated pharmaceutical operations.Location: Onsite in QC Laboratory, Loughrea, Co. Galway.<hr data-start="662" data-end="665"><h2 data-start="667" data-end="696">Key Responsibilities</h2><ul data-start="697" data-end="1860"><li data-start="697" data-end="803">Define and implement the QA strategy for SAP ERP in line with regulatory and operational requirements.</li><li data-start="804" data-end="886">Establish and enforce quality governance frameworks, policies, and procedures.</li><li data-start="887" data-end="1001">Lead the QA workstream within the SAP S/4HANA Cloud ERP programme, following an &ldquo;Adopt not Adapt&rdquo; methodology.</li><li data-start="1002" data-end="1150">Collaborate with SAP consultants, business stakeholders, and technical teams to embed quality requirements into system design and configuration.</li><li data-start="1151" data-end="1240">Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.</li><li data-start="1241" data-end="1332">Support the Computer System Validation (CSV) lead and coordinate with external vendors.</li><li data-start="1333" data-end="1378">Review and approve project documentation.</li><li data-start="1379" data-end="1503">Implement audit trails, electronic signatures, and access controls to guarantee inspection readiness and data integrity.</li><li data-start="1504" data-end="1602">Act as the main liaison between stakeholders and project teams on all quality-related matters.</li><li data-start="1603" data-end="1683">Facilitate workshops and training sessions to strengthen compliance culture.</li><li data-start="1684" data-end="1754">Monitor quality KPIs and drive continuous improvement initiatives.</li><li data-start="1755" data-end="1860">Provide quality insights to manufacturing, supply chain, and regulatory teams to optimise operations.</li></ul><hr data-start="1862" data-end="1865"><h2 data-start="1867" data-end="1897">Skills &amp; Competencies</h2><ul data-start="1898" data-end="2649"><li data-start="1898" data-end="1994">In-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.</li><li data-start="1995" data-end="2179">Practical experience with:<ul data-start="2028" data-end="2179"><li data-start="2028" data-end="2062">Quality Management (QM) module</li><li data-start="2065" data-end="2102">Batch management and traceability</li><li data-start="2105" data-end="2142">Inspection planning and execution</li><li data-start="2145" data-end="2179">Integration with LIMS and EQMS</li></ul></li><li data-start="2180" data-end="2252">Familiarity with SAP Best Practices and Fit-to-Standard methodology.</li><li data-start="2253" data-end="2336">Strong understanding of GDP, GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA++.</li><li data-start="2337" data-end="2398">Experience supporting CSV activities and audit readiness.</li><li data-start="2399" data-end="2474">Proven leadership of QA workstreams in large-scale ERP implementations.</li><li data-start="2475" data-end="2576">Proficiency with SAP Signavio or similar tools for process modelling and validation traceability.</li><li data-start="2577" data-end="2649">Strong leadership, communication, and stakeholder management skills.</li></ul><hr data-start="2651" data-end="2654"><h2 data-start="2656" data-end="2692">Qualifications &amp; Experience</h2><ul data-start="2693" data-end="3112"><li data-start="2693" data-end="2787">5+ years of Quality Assurance experience in regulated pharmaceutical or CDMO environments.</li><li data-start="2788" data-end="2867">Extensive ERP implementation experience with a strong focus on SAP systems.</li><li data-start="2868" data-end="2930">Demonstrated leadership in CSV and QA-driven ERP projects.</li><li data-start="2931" data-end="3029">Familiarity with tools such as SAP Signavio for process modelling and validation traceability.</li><li data-start="3030" data-end="3112">Experience with AI/ML tools for quality monitoring and validation (desirable).</li></ul>

Quality Assurance Lead - ERP Implementation Project

Senior Engineer - Injection Molding As a Senior Engineer, you will take a key position in advancing our manufacturing capabilities. You&rsquo;ll work closely with Operations, Contract Manufacturing, Global Engineering, NPD, and R&amp;D teams, providing expertise in injection molding and related technologies. From developing new processes to guiding cross-functional teams, this role gives you the chance to shape both products and processes that directly improve patient outcomes.Main Responsibilities<ul><li>Act as project lead on cross-functional initiatives, ensuring milestones are achieved and technical solutions are implemented effectively.</li><li>Oversee the introduction of new molds, managing everything from supplier engagement to installation and qualification (IQ/OQ/PQ).</li><li>Apply scientific molding principles and DOE methodologies to refine and troubleshoot processes.</li><li>Offer technical input and support across product development and day-to-day manufacturing.</li><li>Build strong partnerships with suppliers and colleagues to bring new equipment and technologies online.</li><li>Evaluate projects not just from a technical perspective but also in terms of cost, value, and long-term performance.</li></ul>Qualifications &amp; Experience <ul><li>Degree in Mechanical, Electrical, Chemical Engineering, or equivalent.</li><li>5&ndash;8 years of engineering experience, including at least 3 years in project leadership and mold qualification.</li><li>Deep understanding of injection molding systems, tooling, and polymers.</li><li>Skilled with CAD tools (SolidWorks preferred) and confident with MS Office.</li><li>A strong communicator and problem-solver, with the ability to lead and influence teams.</li></ul>Desired Skills &amp; Experience <ul><li>RJG Master Molder I &amp; II certification.</li><li>Previous experience in the medical device sector.</li><li>Knowledge of FDA/ISO requirements.</li><li>Six Sigma Green or Black Belt certification.</li><li>Hands-on background in mold design or mold making.</li></ul>For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a> Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review

Senior Engineer - Injection Moulding 

Automation Technician - Manufacturing&nbsp; We are seeking a motivated Project/Automation Engineer to support the development of new technology and optimize existing systems to enhance production, quality, profitability, and safety. This role involves the planning, scheduling, and execution of projects, ensuring delivery within committed timelines. You will also contribute to facility expansions and modifications, working closely with engineering management and production support teams. Kay Responsibilities<ul><li>Support the development of new and existing technology and production lines to improve efficiency, quality, and safety.</li><li>Plan, execute, and document project assignments in line with governance policies, timelines, and project goals.</li><li>Ensure all technical and customer requirements are achieved.</li><li>Develop and maintain validation and project management documentation.</li><li>Participate in regular project reviews with teams and management.</li><li>Perform design work, layouts, sketches, and concepts for projects and plant layouts.</li><li>Review and develop engineering change requests for modifications to processes, equipment, and facilities.</li><li>Troubleshoot and repair automation equipment.</li><li>Evaluate and maintain machine safety systems to protect operators.</li><li>Monitor production data to ensure automation lines achieve targeted OEE and output.</li><li>Maintain product quality through effective automation maintenance and operation.</li><li>Provide timely updates to shift leaders and program managers regarding downtime or maintenance issues.</li><li>Interface daily with the Engineering Manager and shift support staff.</li><li>Ensure compliance with all safety, regulatory, and quality standards.</li><li>Support and maintain automation equipment, including: Assembly machines/fixtures, Label applicators, Robots and end of arms, Separators, Test equipment &amp; Other assigned equipment</li></ul>Qualifications &amp; Experience <ul><li>Associate&rsquo;s Degree in a relevant Engineering discipline (required).</li><li>Bachelor&rsquo;s Degree in a relevant Engineering discipline (preferred).</li><li>Minimum 3 years&rsquo; experience in the medical device or other regulated industry (required).</li><li>Minimum 3 years&rsquo; experience supporting technical project management (preferred).</li></ul>Skills &amp; Knowledge&nbsp; <ul><li>Background in medical devices/pharmaceuticals is a plus.</li><li>Strong knowledge of quality systems requirements, FDA QSR, cGMP, and relevant ISO standards.</li><li>Travel &amp; Physical Requirements</li><li>Travel: Up to 5% (approx. 13 business days per year).</li><li>Ability to exert up to 20lbs/9kg of force frequently.</li><li>Must be able to work a standard 40-hour week, with overtime/irregular hours as required.</li><li>May require standing or sitting for extended periods.</li><li>Must tolerate manufacturing environment conditions (plastic injection molding, fumes, particulates).</li></ul>For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a> Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review

Automation Technician - Manufacturing 

Manufacturing Engineer II x2&nbsp;Location: GalwayJob Type: Full-Time Contract RoleExperience Level: Mid-Level&nbsp;Job Summary: As a Manufacturing Engineer II, you will play a crucial role in the production of self-expanding Stents products. You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of our manufacturing processes. Your efforts will directly impact the improvement of our processes and the successful completion of our projects.Key Responsibilities:<ul><li>Technical Expertise: Apply advanced engineering principles to support and improve manufacturing processes within the medical device sector.</li><li>Problem Solving: Identify and resolve manufacturing issues to maintain product quality and production efficiency.</li><li>Validation Experience: Conduct and document validation activities to ensure compliance with regulatory requirements and quality standards.</li><li>Process Improvement: Continuously evaluate and enhance manufacturing processes to optimize productivity and reduce costs.</li><li>Project Management: Lead and participate in project teams, ensuring timely completion of deliverables within budget.</li><li>Teamwork: Collaborate effectively with cross-functional teams including R&amp;D, Quality, and Operations to achieve common goals.</li><li>Communication Skills: Clearly and effectively communicate technical information to team members, stakeholders, and management.</li></ul>Qualifications:<ul><li>Minimum of 3 years of experience in a manufacturing engineering role, preferably within the medical device or related industry.</li><li>Strong technical background with a proven track record in problem-solving and process improvement.</li><li>Hands-on experience with validation processes and documentation.</li><li>Excellent project management skills with the ability to manage multiple projects simultaneously.</li><li>Effective teamwork and interpersonal skills.</li><li>Strong verbal and written communication skills.</li></ul>&nbsp;

Manufacturing Engineer II X2 

Design Engineer&nbsp; A leading designer and manufacturer of high-reliability film capacitors for the power electronics market, supplying low- and medium-voltage film capacitors to industries including industrial, medical, aerospace, automotive, and renewable energy. We are seeking a talented Design Engineer with a multi-skilled engineering background to help design and select capacitors that meet customer needs &mdash; and turn technical requirements into practical, high-performance solutions. Main Responsibilities<ul><li>Collaborate with Design, Engineering &amp; Innovation, Operations, and Sales teams to develop solutions for customer projects.</li><li>Select and design capacitors that meet complex technical specifications.</li><li>Communicate directly with customers to understand requirements and present proposed solutions.</li><li>Build strong relationships with both internal teams and external stakeholders.</li><li>Use CAD tools (SolidWorks or similar) to create and adapt designs.</li><li>Contribute to product development and improvement initiatives.</li><li>Extensive on-the-job training will be provided to familiarise you with products, design capabilities, and manufacturing processes.</li></ul>Qualifications &amp; Experience <ul><li>Bachelor&rsquo;s degree in Industrial, Mechanical, or Electrical Engineering.</li><li>5+ years&rsquo; industry experience in an engineering role.</li><li>Strong technical ability and problem-solving skills.</li><li>Confident communicator with excellent presentation skills.</li><li>Proficiency in MS Office and CAD software (SolidWorks or equivalent).</li><li>Ability to work effectively in a team environment and manage multiple priorities.</li><li>A genuine drive to deliver results and exceed expectations.</li></ul>Why Join <ul><li>Be part of a company with over 40 years of technical expertise and innovation.</li><li>Work on projects across diverse industries including aerospace, medical, and renewable energy.</li><li>Enjoy a collaborative environment with direct access to decision-makers.</li><li>Receive extensive product training and opportunities for professional growth.</li></ul>For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a> Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review

Design Engineer

R&amp;D SupervisorMedical deviceMayoR&amp;D Supervisor &ndash;Global Medical Device LeaderAre you a technical leader with a strong background in R&amp;D and a passion for driving improvements in established medical devices? A global medical device organisation is seeking an R&amp;D Supervisor to lead a high-performing team focused on post-launch product support, technical investigations, and strategic improvement initiatives.This is an exciting opportunity for a hands-on leader who thrives in cross-functional environments and wants to make a direct impact on product performance, cost optimisation, and regulatory compliance.Key Responsibilities:Supervise a Cross-Functional R&amp;D Team: Provide leadership, mentorship, and performance management for a team of engineers and scientists involved in supporting and improving existing products.Manage Core Business Projects: Oversee projects related to product design updates (fit/form/function), cost reduction, supply continuity, root cause investigations, and compliance improvements.Project Planning &amp; Resource Management: Coordinate and schedule team activities, ensuring timely and high-quality delivery of projects in line with business priorities.Ensure Regulatory &amp; Quality Compliance: Uphold medical device standards, ensuring proper documentation, procedures, and quality systems are followed consistently.Foster Cross-Functional Collaboration: Work closely with Operations, Quality, Engineering, Marketing, and other global teams to ensure alignment and effective execution of product support activities.Budget &amp; Vendor Oversight: Manage project budgets and identify qualified external partners when necessary to support internal capabilities and meet deadlines.Qualifications:Experience:5+ years in a technical R&amp;D or process development role within a regulated industry (medical devices preferred)Prior experience supervising or leading technical personnelExposure to materials science, coatings, or polymers is a plusStrong understanding of product lifecycle and sustaining engineering practicesEducation:Bachelor&rsquo;s or Master&rsquo;s degree in Materials Science, Polymer Science, Biomedical Engineering, or a related fieldA PhD is an advantage but not requiredSkills &amp; Attributes:Proven leadership skills with a track record of developing and managing technical teamsAdvanced problem-solving and analytical abilitiesStrong organisational, communication, and project management skillsDeep understanding of regulatory requirements and quality systems for medical devicesExperience in budget management and use of external vendors or consultantsFor further information on this R&amp;D Supervisor role in Mayo please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; https://www.hero.ie/.Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

R&D Supervisor 

<h3 data-start="62" data-end="130">PLC Software Developer &ndash; Medical Device (Limerick, Hybrid)</h3>Our medical device client in Limerick is seeking a PLC Software Developer to join their growing Controls Engineering team. This is a product development role (not manufacturing line support) focused on next-generation robotic pharmacy automation systems.In this role, you&rsquo;ll:<ul data-start="426" data-end="845"><li data-start="426" data-end="568">Design, develop, and implement PLC software (Codesys, Structured Text, object-based programming) for scalable medical device products.</li><li data-start="569" data-end="657">Contribute to system architecture, hardware integration, and control algorithms.</li><li data-start="658" data-end="763">Work in a verification &amp; validation framework within a regulated environment (IEC/ISO standards).</li><li data-start="764" data-end="845">Collaborate with cross-functional teams across Ireland, Austria, and Germany.</li></ul>About you:<ul data-start="864" data-end="1211"><li data-start="864" data-end="937">5+ years&rsquo; experience in PLC development, robotics, or automation.</li><li data-start="938" data-end="1048">Strong knowledge of motion control, distributed/PC-based systems, and best-practice coding principles.</li><li data-start="1049" data-end="1146">Background in Electrical/Mechatronics/Robotics/Computer Science or equivalent experience.</li><li data-start="1147" data-end="1211">Experience in medical device or regulated industries a plus.</li></ul>

Hey there! As an experienced recruitment consultant with a solid track record in the industry. I've got the skills and expertise to make those perfect connections. My experience spans various industries, such as medical devices, pharmaceuticals, Fintech, Medtech, IT, and automotive. Talk about a wide range! My passion for learning knows no bounds. I'm always seeking new knowledge and continuously studying to stay ahead of the game. Because let's face it, staying up-to-date is crucial in this fast-paced world.
As someone who values hard work, I understand the importance of finding a place that respects not only your professional expertise but also who you are as a person. It's all about finding that perfect match where you feel valued and appreciated.
Outside of work I love music and festivals. You might be wondering how that ties into my recruitment work, but here's the thing&mdash;music and festivals are all about creating incredible experiences, bringing people together, and fostering a sense of community. These values align perfectly with my approach to recruitment. I believe in creating meaningful connections, understanding the unique qualities and passions of candidates, and finding the perfect fit where they can thrive and contribute.
If you have any questions about the roles I'm advertising or need assistance with your hiring needs, don't hesitate to reach out. I'm here to guide you, connect the dots, and make your recruitment journey smooth and successful.

Job Details

Senior Controls Engineer

Recruitment Consultant

Senior Controls Engineer

PLC Software Developer – Medical Device (Limerick, Hybrid)

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