A global medical technology leader is looking for a Senior Quality Systems Engineer in Shannon, County Clare, Ireland. This role focuses on ensuring compliance with Quality Management System (QMS) requirements and enhancing quality processes. Responsibilities include leading internal and external audits, driving improvements, and collaborating with teams to resolve quality issues. Ideal candidates will have a Bachelor's degree and over 5 years of experience in quality systems within a regulated industry, with expertise in CAPA and project management. The company offers a dynamic work environment and opportunities for innovation. #J-18808-Ljbffr
Senior Quality Systems Engineer 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. The Senior Quality Systems Engineer is responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS) at our Shannon and Galway site. What You’ll Create Impact Develop, implement, and continuously improve QMS processes, procedures, and instructions. Act as SME for CAPA and Issue Evaluations, ensuring timely and effective closure. Lead and maintain the internal audit program and support external audits of the site. Host and manage regulatory inspections, including Notified Bodies (NBs) and FDA visits. Support change management activities, preferably using Windchill or similar PLM systems. Drive simplification of processes and implement innovative, technology-driven solutions, including AI-based tools for quality improvement. Prepare and lead Quality Management Reviews to ensure QMS effectiveness. Collaborate with operational/manufacturing groups and suppliers to resolve and prevent quality issues. Provide training and coaching on QMS requirements to business users. What Makes You Stand Out Strong knowledge of quality assurance techniques (inspection methods, statistical sampling, validation, SPC). Expertise in CAPA, change management, and internal auditing. Ability to apply innovative solutions and technology to optimize quality systems. Excellent communication and leadership skills; ability to host regulators confidently. Project management skills with ability to manage diverse tasks simultaneously. Ability to work independently and make sound decisions. Your Background Bachelor’s degree in engineering or scientific discipline (or equivalent with CQE certification). Minimum 5+ years of experience in Quality Systems, Quality Engineering, or Quality Compliance within a regulated industry (medical device preferred). Experience with Windchill or similar PLM systems highly desirable. Proven experience hosting regulatory inspections (NBs, FDA). Familiarity with Microsoft Office Suite. EOE/M/F/Vet/Disability Location: Limerick, County Limerick, Ireland #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 focus on development opportunities, robust employee resource groups (ERGs), 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 The purpose of this position is to collaborate closely with various departments, including IT, business units, and the AI development teams, to ensure the successful implementation and monitoring of AI systems for our manufacturing sites globally. You will provide user support as well as update functional specifications, software requirements, data migration plans/reports, workflows and troubleshooting. The person will act as a cross‑functional, inter‑business unit resource which ensures our automated quality processes are compliant with all applicable regulations. As such, the incumbent must be technically knowledgeable in multiple disciplines including information technology, quality, and GxP processes. How You’ll Create Impact Facilitates and / or provides support for all application users, including training and troubleshooting. Act as technical expert for system requirements and updates. Ensure systems are available, globally 7x24. Includes troubleshooting and problem resolution. Support activities for process and system improvements, focusing on compliant, yet lean initiatives. Manage and confront issues as they arise. Formulate cross‑functional teams, gaining consensus of requirements and approach and global teams. Prepares and assures completion of required personnel training. Proactively works to ensure automated systems related to quality systems meet or exceed all applicable regulations and standards. Lead procedures and validation activities for any manufacturing software system tools. What Makes You Stand Out Ideally possesses a broad business perspective, including understanding the processes used within the respective areas, project management and Zimmer business goals of cost, quality and customer satisfaction. Must work well with others and interact effectively with all levels, technical information, outside contacts and support personnel. Must be creative in solving problems with new products to maintain scheduled completion dates. Must possess an understanding of GxP regulations, state‑of‑the‑art validation techniques. Must be able to develop, implement, and execute system protocols. Requires an understanding of process, equipment, software, and infrastructure, with an emphasis on software. Requires knowledge of Systems. Your Background Bachelor’s degree in computer science or an appropriate engineering discipline. A minimum of one year of experience supporting applications is required. Familiarity with Good Manufacturing Practices and QSR/ISO standards required. 5–7+ years of professional work experience required. EOE/M/F/Vet/Disability Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Medical Equipment Manufacturing #J-18808-Ljbffr
Join to apply for the Plant Strategic Direct Sourcing Lead role at Zimmer Biomet 3 days ago Be among the first 25 applicants 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 The Plant Strategic Sourcing Lead is responsible for executing sourcing strategies at the plant level, driving total cost reduction, improving supplier performance, and aligning sourcing initiatives with regional and global supply chain objectives. The role focuses on sourcing and NPI projects, cross‑functional collaboration, supplier development and process optimization to achieve the highest levels of cost‑effectiveness, delivery performance and quality in a regulated medical device manufacturing environment. How You'll Create Impact Manage sourcing projects (PMO, Gantt, …). Lead the integration of Sourcing and NPI projects into the plant and supply chain. Actively participate in and drive new product introduction (NPI) projects. Drive and report supplier performance. Drive sourcing and supplier strategies, ensuring alignment with EMEA/Global category strategies. Drive cost reduction, working capital improvements, and supplier consolidation. Manage and analyse EOM (End‑of‑Month) reporting based on performance metrics and KPIs. Conduct quarterly sourcing reviews, spend analysis, and lead improvement initiatives. Manage the annual budget process. Collaborate with project owners, category managers, and plant leads to ensure aligned sourcing execution. Collaborate with stakeholders in contract negotiations, supplier selection, and purchasing agreements for plant‑specific materials and services. Act as the first point of escalation for plant‑level supplier issues. Ensure compliance with legal, regulatory, and quality requirements. Excellent communication skills in English. What Makes You Stand Out Cross‑functional team collaboration. Building strong, positive relationships. Strong communicator. Resilience. Attention to detail. Problem solver. Your Background Bachelor's degree in Business, Engineering, Supply Chain or a related field. Min. 3‑5 years of experience in strategic sourcing, procurement or supply chain, preferably in a medical device or regulated manufacturing environment. Demonstrated success in contract negotiation, supplier performance management, and cross‑functional collaboration. Strong analytical, reporting and project management skills. Ability to manage multiple priorities in a fast‑paced environment. Experienced in handling complex procurement scenarios, including supply issues and escalation management. Expert in MS‑Office, specifically Excel. Excellent knowledge of MRP (Material Requirements Planning). Proficiency in JDE, SAP‑GMS and Ariba would be a plus. Travel Expectations Partially remote, expected work on site 2‑3 days. EOE/M/F/Vet/Disability Seniority level Mid‑Senior level Employment type Full‑time Job function Purchasing and Supply Chain Industries Medical Equipment Manufacturing Get notified about new Strategic Sourcing Lead jobs in Shannon, County Clare, Ireland . #J-18808-Ljbffr
