Overview At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. What You Can Expect What You Can Expect Senior Finance Analyst for Manufacturing Site in Shannon. Provide support to the management team via providing a monthly analysis of actual – v – budget & projected spend and other reports of key financial data. Make recommendations to management to drive business performance and ensure focus is to continually control the cost base of the facilities. Provide financial and analytical support to business partners for key projects or productivity/cost savings initiatives. Preparation of Opex & Capex for Budgets and Projections. Ensure key business and financial processes (eg Inventory, Capital, GL etc) are implemented in an efficient and timely manner. Ensure all corporate and project timelines are met. Ensure Capital Investment is monitored and accurately recorded. Review of Month End accounts & Balance Sheet Reconciliations for area of responsibility. Ensure accuracy of the General Ledger and other financial data. Ensure compliance with corporate/local policies and control procedures. Implement & maintain strong internal controls within the plants to ensure excellent audit results – Internal, External & Sox. Lead key finance projects including transformation, process and system upgrades and other business requirements. Actively seek to implement continuous improvement in area of responsibility. Other accounting duties as and when needed. How You\'ll Create Impact Highly motivated, self starter willing to meet strict deadlines and time constraints. Able to work with minimal supervision, while maintaining the balance of keeping the Finance Assoc. Director informed on relevant issues. Results and performance driven. Must demonstrate ability to work well in a dynamic, global organization environment. Excellent attention to detail and analytical skills. Good problem-solving skills. Proactive, enthusiastic attitude to work and committed to continuous process improvement. Ability to clearly and concisely communicate financial matters to business partners. Demonstrates characteristics of high potential for future developmental opportunities. What Makes You Stand Out Recognised Accountancy qualification. 5+ years PQE in management/cost accounting, in a manufacturing environment essential (preferably a US multinational) Working at similar level in an organization. Excellent working knowledge of standard costing and inventory transactions. High degree of computer literacy. Experience of working with integrated business systems (preferably JD Edwards). Experience working with Hyperion would be advantageous. Travel Expectations Up to 10% EOE/M/F/Vet/Disability #J-18808-Ljbffr
Zimmer Biomet is looking for a Senior Finance Analyst to join their team in Shannon, Ireland. This role involves providing financial support through analysis and reporting, ensuring compliance with corporate policies, and leading finance projects. Ideal candidates will have over 5 years of experience in management or cost accounting within the manufacturing sector, excellent analytical skills, and a recognised accountancy qualification. Join a company dedicated to innovation and employee development. #J-18808-Ljbffr
Overview At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. What You Can Expect Responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of new orthopedic devices, evaluating changes to orthopedic devices and the manufacturing processes. Regulatory submissions can include, but are not limited to EU class III, IIb, IIa and Ir Technical Documentation, US FDA Class III PMA and Class II (510k) submissions as well as supporting global submissions. How You\u2019ll Create Impact Develop Regulatory strategy for NPI projects, changes to devices and changes to manufacturing processes. Provide support, training and guidance to junior RA team members. Review as applicable documents created by junior RA team members. Develop documents to submit to Notified Bodies and FDA including: Technical Documentation MDR (EU) 2017/745 Change notifications. Premarket notifications (510(k)). Premarket Applications (PMA) – original, supplements or annual reports. Develop internal documentation when formal FDA submissions are not required (LTF or Memo-to-File). Supports, supervises, approves, and participates (as necessary) in the development of package inserts (IFUs), evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status. Review and approve Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP) and other applicable Clinical documentation such as SSCP. Provide input into Post Market Surveillance Update Reports (PSUR) and review and approve PSURs. Review and approve Engineering Change Requests (ECRs). Development and updating of internal operating procedures. Submit documents to support International registration submission requests. Participate in other RA activities as needed. What Makes You Stand Out Strong Knowledge of EU and USA regulations. Knowledge of international medical device regulations. Strong attention to detail. Strong computer skills, including word processing, spreadsheet and data programs. Good oral and written communication skills. Your Background Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred. A minimum of five years of experience in orthopaedic or medical device industry preferred A minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required Regulatory Affairs Certification (US or EU) preferred A combination of education and experience may be considered Travel Expectations Up to 15% EOE/M/F/Vet/Disability #J-18808-Ljbffr
Zimmer Biomet is looking for someone to oversee project management activities that optimize global Quality Management System processes. This role involves ensuring projects meet technical requirements and deadlines while also acting as a corporate quality subject matter expert. Candidates should have a Bachelor's degree, 6-8 years of experience in quality roles, and at least 2 years in project management, preferably with certifications. Intermediate skills in MS Office are essential, and knowledge of medical device regulations is preferred. #J-18808-Ljbffr
What You Can Expect The primary responsibility for this position will be to oversee project management activities of one or more initiatives to support the optimization of global Quality Management System processes engaging in the design, implementation, and modification of projects. Ensure that projects are completed on schedule and meet technical and scope requirements of the assignment. Secondary responsibilities will include support of the Zimmer Biomet global electronic change management process, corporate document control, and corporate learning management system. How You'll Create Impact 70% - Oversee project management activities for global quality initiatives by: Establishing daily tasks necessary for successful project execution. Collaborating with stakeholders to establish objectives, timelines, milestones, resolve issues. Ensuring task completion by establishing priorities and reaching compromise with team members and functional managers. Recommending project decisions to higher level management. 20% - Act as a corporate quality subject matter expert for the global electronic change management system. 10% - Support corporate document control and learning management systems owners as process backups. What Makes You Stand Out Must be familiar with and understand general quality management system concepts and implementation. Advanced knowledge of project management tools and methods and ability to effectively implement project management strategies across different functional groups. Must be reliable and capable of working with minimal supervision to manage project planning, execution, and follow-up activities. Basic experience or knowledge on issue resolution disciplines (e.g., problem solving/decision making, root cause analysis, etc). Must be able to manage stressful situations and to handle controversial issues. Highly compliance oriented to firmly adhere to the principles of the regulations and standards. Your Background A Bachelor's Degree is required. A degree in a technical discipline is preferred. 6-8 years of experience in a Quality role within a regulated industry, experience in medical devices or pharmaceuticals preferred. At least 2 years’ experience in project management roles required. Project Management certification is strongly preferred. Intermediate skills in MS Office applications or equivalent required. Medical Device regulations knowledge and experience are highly preferred. Travel Expectations Up to 10% EOE/M/F/Vet/Disability #J-18808-Ljbffr
What You Can Expect The primary responsibility for this position will be to oversee project management activities of one or more initiatives to support the optimization of global Quality Management System processes engaging in the design, implementation, and modification of projects. Ensure that projects are completed on schedule and meet technical and scope requirements of the assignment. Secondary responsibilities will include support of the Zimmer Biomet global electronic change management process, corporate document control, and corporate learning management system. How You'll Create Impact 70% - Oversee project management activities for global quality initiatives by: Establishing daily tasks necessary for successful project execution. Collaborating with stakeholders to establish objectives, timelines, milestones, resolve issues. Ensuring task completion by establishing priorities and reaching compromise with team members and functional managers. Recommending project decisions to higher level management. 20% - Act as a corporate quality subject matter expert for the global electronic change management system. 10% - Support corporate document control and learning management systems owners as process backups. What Makes You Stand Out Must be familiar with and understand general quality management system concepts and implementation. Advanced knowledge of project management tools and methods and ability to effectively implement project management strategies across different functional groups. Must be reliable and capable of working with minimal supervision to manage project planning, execution, and follow-up activities. Basic experience or knowledge on issue resolution disciplines (e.g., problem solving/decision making, root cause analysis, etc). Must be able to manage stressful situations and to handle controversial issues. Highly compliance oriented to firmly adhere to the principles of the regulations and standards. Your Background A Bachelor's Degree is required. A degree in a technical discipline is preferred. 6-8 years of experience in a Quality role within a regulated industry, experience in medical devices or pharmaceuticals preferred. At least 2 years’ experience in project management roles required. Project Management certification is strongly preferred. Intermediate skills in MS Office applications or equivalent required. Medical Device regulations knowledge and experience are highly preferred. Travel Expectations Up to 10% EOE/M/F/Vet/Disability #J-18808-Ljbffr
Zimmer Biomet is seeking a Project Manager to oversee initiatives for optimizing global Quality Management System processes in Galway, Ireland. This role involves managing project activities, ensuring timely completion, and providing subject matter expertise for corporate quality systems. Candidates typically have 6-8 years of experience in a quality role, with at least 2 years in project management. A Bachelor's Degree in a technical discipline is required, and project management certification is preferred. #J-18808-Ljbffr
A leading medical device company in Galway, Ireland is seeking a Regulatory Affairs Specialist to be responsible for ensuring proper regulatory submissions for orthopedic devices. This role involves developing regulatory strategies for new projects, supporting junior team members, and reviewing essential clinical documentation. Ideal candidates will have over five years of experience in the orthopedic or medical device industry and strong knowledge of EU and US regulations, as well as a relevant bachelor's degree. #J-18808-Ljbffr
Responsibilities Responsible for ensuring that regulatory submissions are appropriately developed for approval and clearance of new orthopedic devices, evaluating changes to orthopedic devices and the manufacturing processes. Regulatory submissions can include, but are not limited to EU class III, IIb, IIa and Ir Technical Documentation, US FDA Class III PMA and Class II (510k) submissions as well as supporting global submissions. Develop regulatory strategy for NPI projects, changes to devices and changes to manufacturing processes. Provide support, training and guidance to junior RA team members. Review documents created by junior RA team members as applicable. Develop documents to submit to Notified Bodies and FDA including: Technical Documentation MDR (EU) 2017/745). Change notifications. Premarket notifications (510(k)). Premarket Applications (PMA) – original, supplements or annual reports. Develop internal documentation when formal FDA submissions are not required (LTF or Memo-to-File). Supports, supervises, approves, and participates (as necessary) in the development of package inserts (IFUs), evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status. Review and approve Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP) and other applicable clinical documentation such as SSCP. Provide input into Post Market Surveillance Update Reports (PSUR) and review and approve PSURs. Review and approve Engineering Change Requests (ECRs). Development and updating of internal operating procedures. Submit documents to support International registration submission requests. Participate in other RA activities as needed. Qualifications Strong knowledge of EU and USA regulations. Knowledge of international medical device regulations. Strong attention to detail. Strong computer skills, including word processing, spreadsheet and data programs. Good oral and written communication skills. Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred. A minimum of five years of experience in orthopaedic or medical device industry preferred. A minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required. Regulatory Affairs Certification (US or EU) preferred. A combination of education and experience may be considered. Travel Expectations Up to 15%. EOE/M/F/Vet/Disability #J-18808-Ljbffr
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives, and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognised. What You Can Expect Support the development, implementation, and training of Lean tools and concepts from incoming to shipment at Zimmer Biomet large site or multiple production sites. Responsible for the overall development program which teaches and promotes efficient, quality, lean, and cost‑effective operation and manufacturing processes using Lean Production Methods. Assist in operationalizing the site strategy on the shop floor. Support departments in identifying operational waste and areas for improved operational effectiveness. Working collaboratively with the Engineering Team, assist in determining, deploying, and training the right development plans and corresponding implementation of Lean concepts within the targeted department. Manage and track specific deployment projects, create and modify development procedures, and conduct kick‑off and site activities to maximize deployment effectiveness and to meet stated objectives in the areas of quality, lead time/delivery, and total cost of product/service goals. How You’ll Create Impact Drive continuous improvement, cost savings, and continuous improvement culture across the operations organization. Assist with establishing governance, standards, measurement, and reporting processes to evolve the OPEX infrastructure and systems for the manufacturing organization. Implement Lean Kanban, JIT, Kaizen, Jidoka, Heijunka, 5S, Visual Management, and other lead philosophies at production sites to improve the overall flow of materials and information. Identify and facilitate process improvement projects, trainings, and workshops to drive cultural change. Perform program management activities with site‑specific projects while monitoring operation progress against stated objectives and goals. Conduct operational assessments and identify initial gaps while creating specific development action plans to address the gaps. Support curriculum development and refine training material use to deploy the Lean Manufacturing philosophy. Conduct root cause analysis to determine metrics and to troubleshoot manufacturing, business, and assembly issues as well as material flow, projects plans, production capacity, and facility design. Create process documentation in support of all activities as needed. Drive value stream mapping to define "As‑Is" Analysis and the transition to Future State. Act as a change agent for continuous improvement efforts that cross clients, sites, and processes. Assist with the deployment of mechanisms for knowledge sharing and best practice transfer to replicate and accelerate improvement efforts. Develop, evaluate, and improve manufacturing methods as it relates to both new product and current product. Confer with management and sets standards for efficient production methods. Estimate production times, process efficiencies, and related costs to provide recommendations and direction for change decisions. Coach and mentor plant project and certification candidates to ensure their continued development in Six Sigma, Lean Manufacturing, and other continuous improvement methodologies. Build and lead a strong internal team of results‑driven, continuous improvement facilitators. Continuously challenge team members to find opportunities for continuous improvement and to raise the bar for performance. Partner with other key stakeholders and search for innovative opportunities. Ensure all initiatives and efforts contribute to the company's long‑term goals and objectives. This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential functions for purposes of the Americans with Disabilities Act. What Makes You Stand Out Extensive knowledge of Lean tools, concepts, and plant‑wide application within manufacturing and processing facilities. Demonstrated ability to apply Lean concepts to improve overall manufacturing effectiveness, ensuring that the right quantity of the right parts is delivered at the right time. Advanced knowledge of analytical/statistical problem‑solving tools (DMAIC/PDCA/8 Disciplines). Demonstrated ability to develop and refine training material for maximum effectiveness. Excellent written, presentation, and communication skills with the ability to articulate complex ideas and strategies clearly and persuasively to diverse audiences at various organizational levels. Ability to work with and influence others in a fast‑paced environment. Ability to work across divisions and functions to influence change across the organization and unleash full potential as a company and as individuals. Proven ability to continuously improve processes and profitability through meaningful and appropriate cost reductions. Able to take action in solving problems and making decisions while exhibiting judgement and a realistic understanding of issues, able to use reason, even when dealing with emotional topics. An understanding of and proficiency in Change Management. Your Background Bachelor's Degree in Industrial Engineering, Engineering, Supply Chain Management, Business Administration required. Five years experience in Lean application and/or training in an industrial or manufacturing setting required. Six Sigma, Lean Manufacturing, or equivalent certification required. Experience leading teams required. Advanced skills in statistical software packages (Minitab, Visio, etc.) and MS Office required. Travel Expectations Up to 25% EOE/M/F/Vet/Disability #J-18808-Ljbffr
