15h Left Senior Quality Systems Engineer
10 hours ago
Position: Quality Systems Engineer
Reporting to: Quality Systems Manager
Join a team that is passionate about improving healthcare outcomes and ensuring the highest standards in medical device manufacturing. This exciting opportunity as a Quality Systems Engineer with a leading organisation offers the chance to work in a collaborative, innovative environment while enjoying the vibrant community and exceptional quality of life in Limerick City, Ireland.
Key Responsibilities
1. Internal Audit System Management:
Maintain and oversee the Internal Audit System as a lead Quality Auditor, supported by a team of internal auditors. Conduct comprehensive internal audits across all aspects of the Quality Management System (QMS) to ensure compliance with relevant regulations.
2. Regulatory and Corporate Audit Support:
Organise and manage site preparations for Regulatory and Corporate Audits. Host audits and manage backroom operations to ensure smooth execution.
3. Standards and Regulatory Compliance:
Manage the standards process, ensuring timely assessment and compliance with evolving regulatory requirements. Assess regulatory intelligence and implement necessary QMS updates to maintain compliance. Act as the Subject Matter Expert (SME) for Global Good Documentation Practices (GDP) and lead updates within the QMS.
4. Process Improvement and Validation:
Lead QMS software validation projects and drive assigned process improvement initiatives. Identify and implement opportunities for improvement proactively.
5. Supplier Audits:
Conduct supplier audits to ensure alignment with the organisation’s stringent quality standards.
6. Documentation and Training:
Prepare, implement, and analyse key Quality Systems documentation. Deliver training on the Quality Manual and critical Quality Systems procedures.
7. Quality Assurance Support:
Progress and lead Corrective and Preventive Actions (CAPAs) within Quality Assurance. Provide support to the CAPA programme and ensure meaningful quality measurement. Prepare and present Management Review documentation.
8. Leadership and Mentorship:
Mentor team members to support their development and successful completion of activities. Ensure prioritisation and timely resolution of internal or external quality issues. Provide inputs to KPIs and Management Review while adhering to the organisation’s Code of Conduct.
Qualifications and Requirements
1. A third-level qualification in Science, Engineering, or a related technical discipline.
2. A minimum of 6 years of experience with ISO13485, ISO14971, the EU Medical Device Regulation 2017/745, FDA QSR (21 CFR Part 820 and Part 11), ideally within the medical device industry.
3. Qualified and experienced Lead Auditor, preferably in the Medical Device sector.
4. Exceptional interpersonal and communication skills, with the confidence to challenge opinions and ensure compliance.
5. High attention to detail, excellent organisational skills, and proven problem-solving capabilities.
6. Proficiency in Microsoft Office.
7. Willingness and ability to travel for company business.
Why Join Us?
Located on the accessible outskirts of Limerick City, Ireland, this organisation offers an opportunity to work at the forefront of medical device innovation. Enjoy a dynamic work culture while living in a city known for its rich history, welcoming community, and excellent quality of life.
This is more than a job—it’s a chance to make a real impact in a company dedicated to improving lives worldwide. If you’re a detail-oriented, self-motivated professional with a passion for quality systems, apply today to join the team
#J-18808-Ljbffr
-
15h Left: Quality Engineer 2
24 hours ago
Limerick, Ireland Cook Medical Full timeOverview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues,...
-
Senior Cloud Software Engineer EDA
10 hours ago
Limerick, Ireland Cpl Healthcare Full timeOur client is an innovation leader in automation and digitalization. They are in the process of developing a platform that will enable large EDA workloads to be executed efficiently across various Cloud Platforms and in hybrid ground-to-cloud environments. The work is as varied as it is interesting, developing everything from cloud orchestration elements to...
-
Limerick, Ireland Wallace Myers International Full timeWe are currently seeking a Mechanical Design Engineer to join the client's team in Limerick. This is a permanent role in a friendly and dynamic company that offers excellent opportunities for career development, supported by a structured mentoring system. As part of our close-knit team, you will work on a broad range of projects across multiple sectors,...
-
(15h Left) Project Engineer
10 hours ago
Limerick, Ireland Quanta Consultancy Services Ltd Full timeProject Engineer - Pharmaceuticals - 12-Month Contract - €45-55 per hour Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around...
-
Limerick, Ireland RedChair Recruitment Full timeOur client in Tralee, Co. Kerry is looking for a Senior Quality Assurance Engineer that can ensure that all the software used on our platforms is operating according to the relevant specification. Develop Automation, perform System testing and drive quality assurance of code and configuration. Document test activities, log defects and ensure that re-testing...
-
▷ 15h Left! Manufacturing Engineer 2
24 hours ago
Limerick, Ireland Cook Medical Full timeOverview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...
-
Senior Electrical Engineer
23 hours ago
Limerick, Ireland Crewit Resourcing Ltd Full timeSenior Electrical EngineerLocation: Limerick, IrelandEmployment Type: PermanentExperience Level: 6+ yearsRole PurposeWe are seeking a Senior Electrical Engineer to join our client's team and lead the engineering activities on specific construction projects. This role involves coordinating technical design with onsite installation and ensuring the...
-
Senior Site Engineer
18 hours ago
Limerick, Ireland Mmd Construction Ltd Full timeMMD Construction are seeking to recruit an experienced Senior Site Engineer on a full time, permanent basis. This is a fantastic opportunity for a highly motivated and ambitious Engineer. Joining MMD Construction means being part of a dynamic team where you will have opportunities to grow your career, work on exciting projects, and contribute to shaping...
-
Quality Assurance Engineer
24 hours ago
Limerick, Ireland RedChair Recruitment Full timeWe are presently recruiting for a Quality Assurance Engineer for our clients in Tralee, County Kerry. Working on one of the largest ever construction projects in Kerry, you will come from a construction background and will support in the aspects of the construction project and ensure that predefined quality standards and regulatory requirements are met. This...
-
15h Left: Buyer
24 hours ago
Limerick, Ireland Harmonics Full timeOverview: Our Client is one of the leading industrial plants in Ireland. They have a history of continuous improvement and innovation and are now considered to be a world leader in the industry. They are seeking an experienced and detail-oriented Buyer to join their team in Limerick. The successful candidate will have a minimum of 5 years of buying...
-
Staff Systems Engineer New
24 hours ago
Limerick, Ireland CPL Full timePlease carefully review the position requirements before submitting a potential candidate for consideration. As the Staff Systems Engineer, you will contribute to cross-disciplinary product development teams and may lead the definition, design, and execution of Systems Engineering activities throughout all phases of the product lifecycle. We are the makers...
-
(Apply Now) Staff Systems Engineer
24 hours ago
Limerick, Ireland FRS Recruitment Full timeStaff Systems Engineer My client, a leading medical device company, is seeking a Staff Systems Engineer to join their innovative team. In this role, you will contribute to cross-disciplinary product development, driving systems engineering activities throughout the product lifecycle and potentially leading key initiatives. Key Responsibilities: Manage and...
-
▷ 15h Left! Construction Project Manager
24 hours ago
Limerick, Ireland Shape Search & Selection Full timeThe Client: My Client are a Connacht-based c.€150m T/O Main Contractor. They have recently won several new Contracts in the Limerick region and are hiring for Project Managers and Senior Engineers. The projects are for Care Homes and Student Accom and Offices. We are looking for 2no. Project Managers with previous experience managing similar builds. You...
-
Senior Electrical Design Engineer New
24 hours ago
Limerick, Ireland CPL Full timeSenior Electrical Design Engineer We are seeking an exceptional Senior Electrical Design Engineer to lead and transform our client's engineering team. This role is critical in driving innovation, maintaining design excellence, and mentoring junior engineers while delivering best-in-class engineering solutions. Key Responsibilities - Lead and manage...
-
3 Days Left! Senior Java Developer
10 hours ago
Limerick, Ireland FRS Recruitment Full timeJob Title: Senior Java Developer Location: Limerick (Hybrid, 2 days per week in the office) The company: A leader in streamlining the design, verification, and manufacturing of integrated circuits (ICs) and electronic systems, dedicated to delivering top-notch solutions that transform businesses. They offer a collaborative culture and commitment to...
-
Senior Energy Engineer
24 hours ago
Limerick, Ireland INFORM3 Recruitment Full timeSenior Energy EngineerLimerick Our client based in Limerick is recruiting for a Senior Energy Engineer to join their team. In this role you will contribute to the delivery of sustainable, innovative and high-quality design solutions for building services systems across a variety of sectors and project size. Responsibilities Estimating energy consumption for...
-
▷ (3 Days Left) Senior Director, Engineering
24 hours ago
Limerick, Ireland Edwards Lifescience Ireland Ltd Full timeLead the engineering team in transfer of products and supporting manufacturing operations. How Will You Make An Impact? Plan and direct complex project activities with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business and develop project plans and schedule, scope, and...
-
Senior Automation Process Engineer
1 week ago
Limerick, Ireland Stem Recruitment Partners Full timeSenior Process Automation Engineer: Main Purpose and Objectives of Position: The Senior Process Automation Engineer will work as a member of the Process Automation Department at our clients site in Limerick. The engineer will provide automation support for automated process equipment across the Limerick site. Personal Considerations: As the Limerick site...
-
Senior Engineer, Industrial Engineering
18 hours ago
Limerick, Ireland Analog Devices, Inc. Full timeSenior Engineer, Industrial Engineering Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare,...
-
▷ [Only 24h Left] Principal Data Engineer
4 hours ago
Limerick, Ireland 1020 ADBV Ireland Full timeAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...