Job Title: DesignQuality Engineer Location: Bray/Ireland/Hybrid Department: Quality Reports To: VP of Quality but day to activities will be the Project Manager for CGM/Biosensors Position Type: Full-Time Job Summary: The Design Quality Engineer will develop and implement compliance strategies to support New Product Introductions (NPI) and current marketed products within the areas of design, design transfer, manufacturing and service. As a critical member of the NPI core team you will ensure adherence to the Quality Management System (QMS) and regulatory requirements. By employing strong critical thinking and influencing skills you will work cross-functionally to ensure robust Quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness and execution and enable commercial delivery of the companys product. Key Responsibilities: Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards. Collaborate with R&D teams to ensure quality considerations are integrated into all stages of the product development lifecycle. Conduct design reviews and risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential risks. Develop and validate test methods, inspection procedures, and quality control processes for new products. Manage design verification and validation activities, ensuring compliance with regulatory requirements and industry standards. Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance. Support the creation and maintenance of Design History Files (DHF) and Device Master Records (DMR) in accordance with regulatory requirements. Lead root cause analysis and corrective and preventive actions (CAPA) for design-related issues. Participate in the development and implementation of quality metrics and key performance indicators (KPIs) to monitor and improve design quality. Prepare and present design quality reports to management, highlighting trends, risks, and opportunities for improvement. Provide training and support to R&D and manufacturing teams on quality principles, procedures, and regulatory requirements. Stay current with industry standards, regulatory updates, and best practices to continuously improve design quality processes. Qualifications: Bachelors degree in Quality Assurance, Engineering, Life Sciences, or a related field. 3+ years of experience in a design quality engineering role, preferably within the medical device industry. In-depth knowledge of QMS standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820. Strong analytical and problem-solving skills with experience in root cause analysis and CAPA. Proficiency in statistical analysis tools and software (e.g., Minitab.). Excellent verbal and written communication skills. Ability to work independently and collaboratively in a team environment. Strong organizational skills and attention to detail. Certification in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.
Job Title: Maintenance Administrator Location: Rathfarnham, Dublin 14 (Office-based) Hours: Monday Thursday 8:30am 5:00pm, Friday 9:00am 5:00pm About Us: A well-established General Building Contractor with a strong reputation for quality and reliability. Our busy office in Rathfarnham supports a skilled maintenance team including carpenters, roofers, general operatives, and a trusted network of subcontractors ensuring all jobs are completed efficiently and to the highest standard. The Role: We are looking for a strong Maintenance Administrator to join our friendly, office-based support team. This role is essential to keeping our maintenance operations running smoothly, from logging jobs and assigning staff/subcontractors, to following up on completion and ensuring accurate invoicing. Reliability and consistency are critical to this position, as the role supports day-to-day operational delivery. Key Responsibilities: Set up jobs on our management system (ABM Windows-based) and assign tasks to staff or subcontractors. Issue job numbers/call sheets and liaise with team members and clients. Follow up persistently by phone to ensure jobs are completed. Collect signed completion documents and submit to clients. Collate paperwork for accounts to ensure timely invoicing. Verify timesheets and day sheets for accuracy; ensure hours and job numbers match. Process purchase and subcontractor invoices, matching them to job sheets for approval. Draft job descriptions for invoicing in ABM. File and manage jobs, quotes, and subcontractor documents. Log reactive, planned, and quoted work to support the Work in Progress schedule. Provide general administrative support to ensure the smooth operation of the maintenance office. Skills & Experience Required: Previous experience in construction, facilities, or a building-related contractor environment preferred, however not essential. Proven reliability, strong attendance, and a consistent work ethic are essential for this role. Strong attention to detail and highly organized. Excellent communication skills fluent English, both written and spoken. Comfortable making phone calls, chasing jobs, and coordinating with multiple stakeholders. Friendly, persistent, proactive, and dependable with a team-oriented approach. Why Join Us: Full-time, stable working hours: Monday Thursday 8:30am 5:00pm, Friday 9:00am 5:00pm. Free on-site parking. Friendly, supportive office environment where teamwork and accountability are valued. Opportunity to work in a varied, busy role with exposure to multiple trades and subcontractors. If you are organized, detail-oriented, reliable, and enjoy supporting a busy maintenance team, we would love to hear from you! Job Types: Full-time, Permanent
Job Description: We are currently looking for FillingOperatives for the Filling Departmentfor our Pharmaceutical client based in Bray. The role involves the following: Preparation of material and paperwork for filling operations Setup of filling activities and completion of product fill according to the SOP Meet daily/weekly yield targets Capping, boxing, labelling and storage of material Operation of equipment Batch paperwork duties Material transactions Housekeeping duties Report any machine issues to the area Leader and to the maintenance department. Ensure stocks of required materials are ready and available at all times. Make-certain that each machine is in good repair and works in accordance to GMP set by the company. Highlight any issues which may lead to failure in Production, Quality or Compliance. To be flexible and willing to carry out overtime as necessary Education and Experience: Preferably at least one (1) years industrial experience in the production/quality control of in vitro diagnostic or similar products. Understanding of production operations, quality assurance/control and cGMP/GLP requirements. To show a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative. Proven team player capable of working within multiple areas whilst maximizing performance. If you have the required experience and are looking for an exciting opportunity in a well established Pharmaceutical company please apply now.
