Teleflex is seeking a responsible individual to support the Global Field Corrective Action (FCA) function in Athlone, Ireland. Key responsibilities include assisting the FCA team in action executions, managing data and administrative tasks, and collaborating with various cross-functional teams. Ideal candidates should possess 3-5 years of experience, strong regulatory knowledge, and excellent organizational and communication skills. This role requires the ability to work under pressure and effectively prioritize tasks in a dynamic environment. #J-18808-Ljbffr
Position Summary Responsible for supporting the Global Field Corrective Action (FCA) function. Responsibilities Supporting the FCA team in the execution of Field Corrective Actions QARA Scheduling, hosting calls with cross functional teams and senior levels of leadership in the absence of FCA management, minute taking and distribution Data maintenance, logging, reporting and filing Global mailbox management and escalation Competent Authority query logging, tracking and responses FCA file compilation and closure Establish, follow, and improve corporate, department, and other company procedures. Support other activities in the post‑market surveillance function as it develops Education / Experience Requirements Knowledge of Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL Minimum 3‑5 years working experience in a similar environment Proven ability to work in a team Attention to detail and accuracy – essential Ability to communicate clearly Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of management Skills that enable coordination of data, including MS‑Office (primarily Excel, PowerPoint, Word, and Outlook) Specialized Skills / Other Requirements Approachable and enthusiastic. Flexible and adaptable Excellent organizational skills with cultural awareness and sensitivity Able to work on own initiative and as a team player Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of management Skills that enable coordination of data, including MS‑Office (primarily Excel, PowerPoint, Word, and Outlook) Good judgment and problem‑solving ability & can understand the impact of decision making on both Teleflex Medical and their customers Able to build good, strong and positive working relationships with cross functional teams across Regions and Functions International & America’s QA/RA Global Manufacturing and Quality Teams Key Relationships / Interfaces Travel Required 10 %. Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com . Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress. #J-18808-Ljbffr
Teleflex in Ireland is seeking a candidate to support the Global Field Corrective Action (FCA) function. In this hybrid role, you will be responsible for executing Field Corrective Actions, managing communications across teams, and maintaining regulatory compliance. The ideal candidate should have 3-5 years of experience in a regulatory environment, strong attention to detail, and proficiency in MS-Office. Join us at Teleflex to contribute to high-quality healthcare solutions! #J-18808-Ljbffr
Position Summary Responsible for supporting the Global Field Corrective Action (FCA) function. Principal Responsibilities Supporting the FCA team in the execution of Field Corrective Actions Scheduling, hosting calls with cross functional teams and senior levels of leadership in the absence of FCA management, minute taking and distribution Data maintenance, logging, reporting and filing Global mailbox management and escalation Competent Authority query logging, tracking and responses FCA file compilation and closure Establish, follow, and improve corporate, department, and other company procedures Support other activities in the post-market surveillance function as it develops Education / Experience Requirements Knowledge of Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR Part 820, ISO 13485, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL Minimum 3-5 years working experience in a similar environment Proven ability to work in a team Attention to detail and accuracy – essential Ability to communicate clearly Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of management Skills that enable coordination of data, including MS-Office (primarily Excel, PowerPoint, Word, and Outlook) Behaviours / Values Approachable and enthusiastic. Flexible and adaptable Excellent organizational skills with cultural awareness and sensitivity Able to work on own initiative and as a team player Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of management Skills that enable coordination of data, including MS-Office (primarily Excel, PowerPoint, Word, and Outlook) Good judgment and problem‑solving ability & can understand the impact of decision making on both Teleflex Medical and their customers Able to build good, strong and positive working relationships with cross functional teams across Regions and Functions International & America’s QA/RA Global Manufacturing and Quality Teams Key Relationships / Interfaces Quality Engineer, Global FCA Manager, Global FCA VP QA/Director level Travel Required 10 %. Working Environment Office/Professional (Hybrid) Equal Opportunity Employer Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com. #J-18808-Ljbffr
Teleflex in Leinster, Ireland, is looking for a Senior Forecasting Scientist to lead the evolution of demand forecasting and revenue signals. You will manage a team and ensure high-accuracy baseline forecasts through advanced statistical modelling. The position requires a strong background in integrating market insights and includes 10% travel. Successful candidates will have a degree in a quantitative field, extensive forecasting experience, and proficiency in Python or R. The work environment is hybrid, promoting teamwork and integrity. #J-18808-Ljbffr
Position Summary Teleflex aims at continuous improvement and sustaining of global Product Lifecycle Management (PLM) processes and systems. These capabilities govern the creation, change, and maintenance of product and process data, ensuring global consistency, compliance, and data integrity. The Senior PLM Engineer / Analyst plays a pivotal role within the Global PLM Team. This role combines hands‑on PLM system expertise, ownership of PLM user training, business analysis, and engineering domain knowledge, while acting as a subject‑matter expert (SME) for change management, product data, and cross‑system integration. The position works closely with Engineering, Quality, Regulatory, Operations, IT, and other workstreams to drive PLM maturity. PLM & Change Management Serve as SME for global change management processes and PLM‑related product data. Drive business ownership of PLM sub‑processes, including design control, change control. Identify process gaps and lead continuous improvement and optimization initiatives. Business Support & Continuity Maintain issue trackers and ensure all business feedback and incidents are documented. Perform data analysis and root‑cause analysis to identify trends and broader impacts. Resolve import validation and interface issues in collaboration with SMEs. Support business users with ticket resolution and PLM best‑practice guidance. Training Ownership Maintain, revise and deliver PLM training materials. Prepare and stage data for testing and training cycles. Lead end‑user training and provide knowledge sharing through documentation. Facilitate maintenance and updates of PLM relevant work instructions. System & Data Management Maintain and support PLM updates including PLM templates, list values, and attributes. Assess and support ad‑hoc data migration and data quality requests. Testing & Validation Trace business requirements to use cases and test scenarios. Develop, execute, and maintain PLM test scripts. Support and execute formal test cycles ensuring end‑to‑end compliance and functionality. Collaborate with IT and technical teams to agree and implement defect fixes. Collaboration & Governance Collaborate effectively with other workstreams (MDG, Data, Quality, OCM, IT, Labelling, Regulatory). Support metric and KPI development to measure PLM process health and maturity. Manage follow‑ups and escalations with users and managers limiting the ageing of the open changes. Education / Experience Requirements Bachelor’s degree (or equivalent) in Engineering, Science, or Medical Technology. 5+ years’ experience in Engineering, Quality, Regulatory, or PLM‑related roles within the medical device industry. Demonstrated experience supporting NPI, sustaining engineering changes, or product transfers. Strong hands‑on experience with PLM system. (2+ years). User Training delivery experience. Experience with SAP ECC / S4 HANA (BOMs, Inspection Plans) is beneficial. Strong understanding of product data structures including BOMs, DMR, DHF, UDI, metadata, and design control. Experience working in global, cross‑functional environments. Specialized Skills / Other Requirements Preferred / Advantageous Six Sigma, Lean, or Project Management certification. Experience with system validation and regulated environments. Knowledge of learning management systems like ComplianceWire. MS Office package, Oracle Agile, SAP. Skills & Competencies Expert knowledge of PLM systems and change management processes. Strong analytical and problem‑solving skills. Excellent communication, facilitation, and stakeholder management skills. Ability to influence and work effectively across all organizational levels. Strong organizational skills with the ability to manage multiple workstreams. Behaviours & Values Approachable, enthusiastic, and collaborative. Self‑starter with strong initiative and accountability. Innovative mindset with continuous improvement focus. Strong sense of ownership and attention to quality and compliance. TRAVEL REQUIRED Up to 10% of international travel, as required. Equal Opportunity Employer Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. Accommodation Note If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com. #J-18808-Ljbffr
Teleflex is looking for a Senior PLM Engineer/Analyst in Athlone, Ireland. This role involves managing product lifecycle processes and acting as a subject-matter expert in PLM systems. Responsibilities include leading user training, maintaining data integrity, and driving continuous process improvement. A bachelor's degree in Engineering or related field along with over 5 years of experience in the medical device industry is required. The successful candidate will exhibit strong analytical skills and effective communication abilities. #J-18808-Ljbffr
Position Summary Lead the delivery of projects to maintain business continuity in areas such as complying with regulations, resolving product performance issues, sustaining supply chain continuity, and improving margins. Principal Responsibilities Work related to products and components may include efforts in all technical phases of product and process development, including design and development planning, requirements definition, product development, root cause analysis, verification/validation and manufacturing aspects using Teleflex design control policies and procedures. Aid in product improvement and cost reduction, facilitate change management and documentation, develop, troubleshoot and maintain manufacturing processes, equipment and systems. Work with component suppliers to develop new components and/or improve existing ones. Perform product testing, create models and prototypes to prove out new designs and changes to existing designs. Directly lead engineering efforts to develop components, specifications and processes with input from technical experts, physicians, marketing and manufacturing adhering to the design control process. Lead projects in the redesign or replacement of existing components/assemblies and processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner. Interface with suppliers, Strategic Sourcing, Quality and Regulatory Affairs to deliver projects. Deliver or lead the resolution of manufacturing issues and conduct improvements of manufacturing processes through the use of statistical data analysis techniques such as Process Capability Studies, DOE and SPC. Provide uniform solutions for international manufacturing operations. For both in house and purchased components, lead the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Define specifications for the generation of products/processes including experimental activity specifications through production lifecycle for the Device Master Record as required. Work related to compliance issues may include research of existing procedures and documentation as well as writing or revising standard operating procedures and other documentation. Meet project objectives, milestones, and target dates. Update and review project progress on an as‑required basis by supervisor. Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts. Direct and/or execute the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of products, processes, test fixtures, equipment, test procedures and documentation. Lead and participate in design and technical phase reviews. Support regulatory submissions and clinical trials as required. Ensure projects are developed and documented compliant with the Quality System. Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards. Education / Experience Requirements Bachelor of Science in Mechanical or Biomedical Engineering preferred; other technical disciplines considered. 2-3 years previous experience in a related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation) may be offset by advanced degrees. Team player with good interpersonal skills. Strong analytical, technical and problem‑solving skills. Previous experience in design of medical devices preferred. Hands‑on experience preferred. Effective verbal and written communication skills. Proficient in Microsoft Office Suite and SolidWorks or equivalent modelling system; familiar with statistical analysis (Minitab) and computerized analysis (FEA) applications. Specialized Skills Self‑motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals. Able to travel domestically and internationally. Travel Required Up to 10% of international travel, as required. EEO Policy Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. #J-18808-Ljbffr
Teleflex seeks an Engineering Lead to oversee project delivery, focusing on business continuity, regulatory compliance, and quality improvement. Candidates should have a Bachelor’s degree in Mechanical or Biomedical Engineering, 2-3 years of relevant experience, and proficiency in tools like SolidWorks and Microsoft Office. Key responsibilities include leading engineering efforts, resolving manufacturing issues, and supporting clinical trials. The role requires strong analytical and problem-solving skills, teamwork, and effective communication. #J-18808-Ljbffr
Position Summary Lead the delivery of projects to maintain business continuity in areas such as complying with regulations, resolving product performance issues, sustaining supply chain continuity, and improving margins. Work related to products and components may include efforts in all technical phases of product and process development, including design and development planning, requirements definition, product development, root cause analysis, verification/validation and manufacturing aspects using Teleflex design control policies and procedures. Aid in product improvement and cost reduction, facilitate change management and documentation, develop, troubleshoot and maintain manufacturing processes, equipment and systems. Work with component suppliers to develop new components and/or improve existing ones. Perform product testing, create models and prototypes to prove out new designs and changes to existing designs. Directly lead engineering efforts to develop components, specifications and processes with input from technical experts, physicians, marketing and manufacturing adhering to the design control process. Lead projects in the redesign or replacement of existing components/assemblies and processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner. Interface with suppliers, Strategic Sourcing, Quality and Regulatory Affairs to deliver projects. Deliver or lead the resolution of manufacturing issues and conduct improvements of manufacturing processes through the use of statistical data analysis techniques such as Process Capability Studies, DOE and SPC. Provide uniform solutions for international manufacturing operations. For both in-house and purchased components, lead the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Define specifications for the generation of products/processes including experimental activity specifications through production lifecycle for the Device Master Record as required. Work related to compliance issues may include research of existing procedures and documentation as well as writing or revising standard operating procedures and other documentation. Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor. Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts. Direct and/or execute the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of products, processes, test fixtures, equipment, test procedures and documentation. Lead and participate in design and technical phase reviews. Support regulatory submissions and clinical trials as required. Ensure projects are developed and documented compliant with the Quality System. Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards. Education / Experience Requirements Bachelor of Science in Mechanical or Biomedical Engineering preferred; other technical disciplines considered. 2-3 years previous experience in a related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation) – may be offset by advanced degrees. Team player with good interpersonal skills. Strong analytical, technical and problem‑solving skills. Previous experience in design of medical devices preferred. Hands‑on experience preferred. Effective verbal and written communication skills. Proficient in Microsoft Office Suite and SolidWorks or equivalent modelling system; familiar with statistical analysis (Minitab) and computerized analysis (FEA) applications. Specialized Skills / Other Requirements Self‑motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals. Able to travel domestically and internationally. Note: As with all positions, due to the dynamic nature of Teleflex Medical Business, key responsibilities will evolve and change over time. Travel Required: Up to 10% of international travel, as required. Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com . #J-18808-Ljbffr
