Sterling Engineering Ltd - Ireland & Europe is looking for a detail-oriented Technical Writer & Document Control specialist in Galway. The role involves creating and managing regulated documentation and ensuring compliance with quality standards such as FDA and ISO 13485. Candidates should have 2–4 years of relevant experience in a regulated industry and strong skills in technical writing and document management. This is an initial 3-month contract with a view for permanency. #J-18808-Ljbffr
We are seeking a detail‑oriented Technical Writer & Document Control to support the creation, revision, and management of regulated documentation within a quality‑driven manufacturing environment. Please note this is an initial 3 month contract role with the view for permanency. Our client is seeking someone is available to join immediately. This role will focus on technical writing, document accuracy and maintaining compliant documentation systems in accordance with FDA, ISO 13485, GMP, and internal quality standards. Key Responsibilities Technical Writing & Documentation Create, revise, format, and maintain technical documentation, including: Standard Operating Procedures (SOPs) Work Instructions Forms, templates, and quality records Collaborate with manufacturing, engineering, and quality teams to gather technical information and translate it into clear, accurate, and user‑friendly documentation. Ensure all documents follow company formatting, version control, and regulatory requirements. Review documentation for consistency, clarity, grammar, and compliance. Document Control & Change Management Manage document revision activities through the change control system. Route, track, approve, and release controlled documents in a timely manner. Maintain document histories, revision logs, and archival records. Support document lifecycle activities including issuance, retrieval, scanning, filing, and archiving. Compliance & Quality Support Ensure documentation complies with FDA regulations, ISO 13485, GMP, and internal quality standards. Support internal and external audits by providing accurate and traceable documentation records. Assist with continuous improvement of documentation processes and templates. Systems & Administrative Support Maintain and update records within the Electronic Document Management System (EDMS). Utilize Microsoft Office tools to develop and manage controlled documentation. Support standardization and organization of quality documentation systems. Required Skills & Qualifications Experience 2–4 years of experience in technical writing, document control, or quality documentation within a regulated industry. Experience in medical device, pharmaceutical, or manufacturing environments preferred. Technical Skills Strong technical writing, editing, and document formatting skills. Proficiency in Microsoft Office Suite, particularly Word and Excel. Experience working with Electronic Document Management Systems (EDMS). Knowledge Understanding of document control processes and quality systems. Familiarity with ISO 13485, FDA 21 CFR Part 820, GMP, and controlled documentation practices. Education Level 6 diploma/certificate or equivalent qualification in Quality, Technical Communication, Life Sciences, or related discipline. For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose #J-18808-Ljbffr
Sterling Engineering Ltd - Ireland & Europe is seeking a Maintenance Technician to ensure equipment reliability and support production targets. This position involves routine maintenance, troubleshooting, and compliance with safety regulations. The ideal candidate will have at least 3 years of experience in high-precision manufacturing and 2 years in a regulated environment. Responsibilities include supporting moulding and assembly operations and performing repairs on electrical and mechanical systems. This is a day-based contract role with potential shift work in the future. #J-18808-Ljbffr
Sterling Engineering Ltd - Ireland & Europe is looking for a Financial Controller to manage financial operations during a phase of expansion. The role involves a hands-on approach to oversee financial reporting, budgeting, and compliance, while also enhancing financial systems and processes. Ideal candidates are qualified accountants with experience in high-growth environments and strong stakeholder management skills. Knowledge of life sciences or regulated industries is a plus. #J-18808-Ljbffr
Financial Controller - Medical Device We are seeking an experienced, energetic and highly resourceful Financial Controller to join a high-growth international business during an exciting phase of expansion. This is a hands‑on, high‑impact role reporting directly to senior leadership. The successful candidate will take ownership of day-to-day financial operations while also playing a key role in building scalable systems, processes, and controls to support continued growth. This role is ideal for someone who thrives in a fast‑paced environment and is comfortable operating across both strategic and operational finance responsibilities. Key Responsibilities Oversee and manage the financial operations across multiple entities, ensuring accuracy, integrity, and timely reporting Act as the primary point of contact for outsourced finance providers, providing direction, oversight and quality control Design, implement, and continuously improve financial processes, controls and policies to support scalable growth Own the month‑end and year‑end close processes, including preparation and review of management accounts Ensure full compliance with statutory, tax, and regulatory requirements across all entities Lead budgeting, forecasting and cash flow management processes Partner with senior leadership to provide financial insight and support strategic decision‑making Prepare board‑level reporting packs and KPI dashboards Support external audits and liaise with auditors, advisors and regulators Drive finance systems and process improvements to enhance efficiency and scalability Key Requirements Qualified accountant (ACA, ACCA, CIMA or equivalent) Proven experience in a Financial Controller or senior finance role within a scaling or high‑growth environment Experience managing outsourced finance teams or shared service providers Strong understanding of financial controls, governance and best‑practice process design Experience in life sciences, biotech, medtech, or other regulated industries is advantageous Ability to operate both strategically and hands‑on within a lean team structure Strong technical literacy with a track record of implementing finance systems or technology solutions to improve efficiency Excellent stakeholder management and communication skills #J-18808-Ljbffr
Maintenance Technician – Moulding & Assembly We are currently recruiting for an Engineering/ Maintenance Technician to join our client. This role focuses on ensuring equipment reliability, supporting production targets, and contributing to continuous improvement and maintenance excellence initiatives. This is an initial Monday to Friday days based contract role with the potential for the role to change to a shift-based working pattern in the future, depending on business and operational requirements. The successful candidate will provide technical maintenance, troubleshooting, calibration, and project support while maintaining compliance with safety and regulatory standards. Support Moulding/Tooling and Assembly operations in line with safety and regulatory requirements. Ensure daily production targets are achieved in partnership with Operations. Perform routine maintenance, troubleshooting, and repairs on: Injection moulding machines and tooling, Automated and semi-automated assembly equipment, Electrical, mechanical, and control systems Act as Subject Matter Expert for assigned equipment and processes. Perform equipment calibration and maintain maintenance/calibration systems. Interpret electrical and mechanical drawings to support fault finding and improvements. Fabricate ad hoc mechanical/electrical components for repairs and upgrades. Participate in continuous improvement and site maintenance excellence initiatives. Complete documentation, commissioning, and validation activities in compliance with cGMP. Execute all maintenance work through the Maximo management system. Support operational and strategic technical projects as required. Requirements Leaving Certificate, Senior Trade Certificate, or FETAC Level 6 (or working toward same). Minimum 3 years’ experience in high-precision manufacturing. Minimum 2 years’ experience in a regulated manufacturing environment. Experience in one or more of the following: Mould tooling, Electrical systems or Automation Strong problem-solving skills with complex equipment. Proficient in computer-interfaced equipment and ERP systems. #J-18808-Ljbffr
The Director of Operations Quality is responsible for leading and overseeing all quality activities related to manufacturing and supply chain operations. This role provides strategic and hands‑on quality leadership, ensuring that production processes, materials, and products meet all applicable regulatory and quality system requirements. The position requires strong operational oversight, team leadership, and the ability to drive continuous improvement within a fast‑paced, growth‑oriented environment. Key Responsibilities Operational Quality Leadership Lead quality activities at manufacturing sites, including incoming inspection, in‑process controls, final release, and batch record review and disposition. Maintain governance over product release and batch record control. Implement and enforce in‑process controls and statistical process control (SPC) to improve yield and reduce variability. Team Management Manage, mentor, and develop the on‑site operations quality team. Recruit, train, and build a high‑performing quality organization. Promote a strong culture of quality across manufacturing operations. Quality Systems & Compliance Approve and control production quality procedures, work instructions, and QC sampling plans. Manage deviations, nonconformances, CAPAs, and root cause investigations; ensure timely closure and effectiveness checks. Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820, and other applicable regulations. Support internal and external audits related to manufacturing; lead responses to operations‑related findings. Validation & Process Control Oversee production‑related validations and qualifications, including process validation, equipment qualification, and environmental controls. Ensure validation documentation is audit‑ready and compliant with regulatory expectations. Support process changes, scale‑up activities, capacity increases, and the transfer of new products or processes into production. Drive supplier quality management for production materials, including supplier selection, audits, performance monitoring, and corrective actions. Manage incoming quality agreements and ensure supplier‑related issues are addressed effectively. Facility & Environmental Controls Oversee routine sterilization controls and lot release processes. Ensure cleanroom control measures are implemented and maintained. Lead quality aspects of facility expansion initiatives, ensuring quality requirements are integrated into new manufacturing layouts and workflows. Performance Monitoring Develop and report KPIs related to product quality, scrap/rework, deviations, and CAPA effectiveness. Provide regular updates to senior leadership on operational quality performance. Professional Qualifications & Attributes Degree in life sciences, engineering, or a related discipline; advanced degree preferred. 8+ years of experience in medical device quality, with significant hands‑on manufacturing and supplier quality experience. Proven leadership experience managing quality teams. Strong knowledge of ISO 13485 and relevant regulatory requirements (MDR, 21 CFR Part 820). Demonstrated experience with production transfers, process validation, and manufacturing CAPA management. Proficient in SPC, FMEA, and root cause analysis tools (8D, Fishbone, 5 Whys). #J-18808-Ljbffr
Sterling Engineering Ltd - Ireland & Europe is looking for a Senior Robotics Engineer to support complex automation solutions in regulated manufacturing. The successful candidate will lead the design, integration, commissioning, and optimization of robotic systems. The ideal background includes a degree in engineering, experience with industrial robots, and leadership skills. This role involves developing robotic solutions, programming robots like Fanuc and KUKA, and ensuring compliance with safety standards. Familiarity with regulated environments such as pharma or food is advantageous. #J-18808-Ljbffr
Sterling Engineering Ltd - Ireland & Europe is seeking a Director of Operations Quality to lead and oversee all quality activities related to manufacturing and supply chain operations. This position requires strong operational oversight, team leadership, and the ability to drive continuous improvement within a fast‑paced environment. Candidates should have a degree in life sciences or engineering and at least 8 years of experience in medical device quality management. Knowledge of ISO 13485 and regulatory compliance is essential. #J-18808-Ljbffr
Warehouse Assistant Role: Warehouse Assistant Reports to: Operations Manager Location: Galway Role Overview The Warehouse Assistant plays a key role in supporting efficient warehouse operations, including the receipt, storage, and distribution of materials, components, and finished products. The role requires strict adherence to safety standards and regulatory requirements within a controlled environment. Key Responsibilities Shipping Coordination Assist R&D, Operations, and Quality teams in preparing shipments and coordinating with carriers to ensure timely dispatch of materials, components, and products. Material Coordination Manage the movement and storage of materials, components, and products within the warehouse and external storage locations. Storage Organisation Ensure all materials and products are stored in accordance with company procedures, including correct labelling and segregation. Collaboration Work closely with cross-functional teams (R&D, Operations, Quality) to support workflow efficiency and resolve any issues. Consumables Management Monitor stock levels of consumables and coordinate ordering to maintain adequate supply. Warehouse Maintenance Maintain a clean, organised, and compliant warehouse environment in line with health and safety regulations. Qualifications & Experience Previous experience in a warehouse or logistics environment (medical or healthcare industry preferred) Familiarity with inventory management systems and basic computer skills Strong attention to detail and accuracy Excellent organisational and time management skills Good communication skills and team-oriented approach Understanding of warehouse health and safety regulations #J-18808-Ljbffr
