A recruitment agency in Shannon, County Clare is seeking an experienced Quality Engineer to develop and maintain quality systems that meet company, customer, and regulatory requirements. The ideal candidate will have at least 3 years of experience in a Quality Assurance role, preferably in the Medical Device or Pharma sectors, and possess strong communication skills. This role involves ensuring compliance with regulations, supporting audits, and producing management reports. Only candidates with a valid work permit will be considered. #J-18808-Ljbffr
About the job Project Engineer Consultant Our client, a global leader in the biopharma sector, is seeking a Project Engineer Consultant to support a major CAPEX project. This role will focus on the delivery of new process systems, ensuring design, installation, and commissioning meet the highest operational and regulatory standards. Essential Duties and Responsibilities include, but are not limited to, Generation User Requirement Specification (URS) for assigned systems. Reviews and approves Basis of Design (BOD) and detail design of assigned systems i. P&IDs, etc. Ensures procurement packages (bill of materials (BOM), datasheets, cutsheets etc) meet the companys equipment specifications. Tracks HAZOP action items and ensures action items are incorporated into system design. Attends 30%, 60% and 90% model reviews ensuring systems meet operational, safety and ergonomic requirements. Reviews and approves system lifecycle documentation (FS. SDS, IO lists, etc) and ensures they meet company requirements. Attends factory acceptance test (FAT) of associated equipment if required. Supervises and executes Site Acceptance Testing (SAT) and commissioning activities. Generates FAT, SAT and commissioning protocols for assigned equipment and ensures protocols meet company specifications. Ensures Vendor Document Requirements (VDR) meet company requirements. Builds Preventative Maintenance (PM) tasks and spare parts lists on Regeneron Computerised Maintenance Management System (CMMS) Education and experience: Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 5 years related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education. Experience with design and commissioning within biopharmaceutical sector would be desirable. Experience with DeltaV would be desirable Skills: Project Engineering & CAPEX Delivery, Commissioning & validation expertise & Regulatory & GMP compliance knowledge #J-18808-Ljbffr
Our client is seeking an experienced Quality Director to join their dynamic team in Shannon Co. Clare. The purpose of this role is to provide strategic leadership, vision, and direction for the Quality function of the company, ensuring the organisation meets and exceeds its business and quality objectives. PRINCIPAL ACCOUNTABILITIES: Strategic Leadership Develop and implement a comprehensive quality strategy aligned with the companys long-term goals. Act as the primary representative for all quality-related matters, ensuring compliance with QSR, FDA, ISO, and other pertinent regulations. Foster a culture of quality and continuous improvement across the organization. Lead the development and execution of quality improvement initiatives and projects. Regulatory Compliance and Quality Systems Ensure the quality management system is robust, effective, and compliant with all relevant standards and regulations. Oversee the internal audit process, ensuring thorough and timely audits. Identify, analyse, and address non-conformances and trends, escalating issues to senior leadership, as necessary. Promote awareness of regulatory and customer requirements throughout the organization. Operational Excellence Provide technical guidance and support for engineering, inspection, and measurement processes. Oversee preventive maintenance and calibration systems to ensure optimal performance. Lead the scrap analysis process and drive initiatives to reduce waste. Participate in and lead problem-solving and corrective action teams. Review and approve CAPA actions, ensuring alignment with quality systems. Mentor and develop the quality team, fostering a high-performance culture. Support the training management process, ensuring staff are well-equipped to meet quality standards. Collaborate with cross-functional teams to drive business success and compliance. KNOWLEDGE/EXPERIENCE: Bachelors degree in a scientific or engineering discipline; advanced degree preferred. Minimum 15 years of quality management experience in the medical device industry or FDA-regulated environment. Proven experience in a senior leadership role (at least 5 to 7 years). In-depth knowledge of Quality Assurance and regulatory requirements. Exceptional communication skills, with the ability to engage and influence all levels of the organization. Strong analytical and problem-solving abilities. Demonstrated success in leading cross-functional teams and driving organizational change. Thorough knowledge of QSR and ISO quality system requirements. Lead Auditor certification. Highly Experienced in medical device operations, with a strong background in QA and people management. If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Skills: quality director, quality manager #J-18808-Ljbffr
A leading recruitment agency is seeking an experienced Quality Director to join a dynamic team in Shannon, County Clare. This role involves providing strategic leadership and direction for the Quality function, ensuring the organization meets its quality objectives. Candidates should have at least 15 years of quality management experience in the medical device industry and demonstrated senior leadership experience. Strong analytical and problem-solving skills are essential, along with exceptional communication abilities. #J-18808-Ljbffr
Our Client based in Shannon Co. Clare is seeking an experienced Quality Engineer to join their dynamic team. The purpose of this role is to develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements. DEPARTMENT Quality REPORTING TO Quality Manager PRINCIPAL ACCOUNTABILITIES Ensure compliance with all pertinent regulations (e.g. FDA, ISO) Ensure compliance and execute activities to the QMS such as non-conformance investigations, CAPA, Change control, complaints, document control, and record retention. Support DHR reviews to ensure timely release of product Develop, implement, and maintain procedures and forms. Support production activities in building quality into the company's products and assuring compliance with the pertinent regulations Lead and execute upgrades to the quality system Participation, coordination, and maintenance of the audit system. Support customer and regulatory audits Ensuring the promotion of the awareness of customer requirements in the company. Producing daily management reports with a view to identifying and making recommendations on improvement opportunities at the company. KNOWLEDGE/EXPERIENCE Bachelors degree in a scientific discipline is an advantage Minimum of 3 years in a Quality Assurance role in Medical Device or Pharma is preferred. Excellent verbal and written communication skills Ability to work in a cross-functional team Good command of MS Office Word, Excel, and PowerPoint Working knowledge and understanding of QSR and ISO quality system requirements Lead Auditor certification or previous auditing experience is preferred Skills Quality Engineer, QA If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. #J-18808-Ljbffr
A leading recruitment firm is seeking a Project Engineer Consultant in Limerick, Ireland. This role involves supporting a major CAPEX project focusing on delivering new process systems within the biopharma sector. The ideal candidate will have a BS/BEng in Chemical, Process or Mechanical engineering, along with 3-5 years of experience, including project engineering and commissioning expertise. Familiarity with DeltaV and regulatory compliance is essential for success in this position. #J-18808-Ljbffr
