Inspect medical devices and components to ensure conformance with design specifications, conduct audits, and perform functional testing to ensure compliance with regulatory and company guidelines. Edwards Lifesciences is a global leader in medical technology, and our manufacturing teams create the tools and devices that transform patients' lives. As a member of our sewing, assembly, delivery, and distribution teams, you will play a critical role in bringing innovative ideas to life. Key Responsibilities: Perform visual, dimensional, and functional inspection on a variety of components and/or finished medical device products using a range of tools and equipment, including magnifying lamps, microscopes, and vision inspection systems. Conduct functional testing of finished medical device products using automated and manual testing equipment to ensure conformance with design specifications. Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards. Review and follow established work instructions and SOPs, including recording traceable information on device history records and utilizing computer programs to perform and/or document specific job tasks. Provide feedback to the team, including escalating work issues and changes in devices and raw materials to higher levels for assessment and correction. Perform line clearance and verification of inspection, and verify manufacturing documents with component and device drawings. Support the training of other inspectors through work demonstration and feedback. Participate in special projects, including Test Method Validations, protocols, and first article inspection. Adhere to company guidelines and policies, including Environmental Health and Safety and Quality guidelines. Requirements: 2 years of previous related experience, including GMP and GDP. H.S. Diploma or equivalent. Additional Skills: Good communication skills. Able to read, comprehend, speak, and write English. Basic computer skills, including working knowledge of manufacturing software. Strict attention to detail. Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity. Full understanding of applicable inspection procedures. Ability to clearly describe and convey nonconformance issues, and enter them into QMS. Ability to work in a team environment and with minimum supervision.
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. In this role you will supervise a team with responsibility for ensuring that the plant operates efficiently in the day-to-day operations and in managing projects to enhance the utilization of the facilities. Key Responsibilities: Supervise facilities employees on day-to-day tasks, including walls, ceiling, floors, and exteriors reparations and maintenance; conduct performance reviews, including resolving performance issues. Ensure employees are appropriately trained to perform assigned work, including LMS System. Run and coordinate facilities projects related to building grounds. Accountable for Facilities Metrics and Reports to pursue world-class performance. Accountable for Facilities PM assigned to electricians and mechanics, as well as all site Facilities work orders. Provide support to the facilities engineer as requested. Assist manufacturing and engineering areas with layout changes as requested. Other duties as assigned by Manager and Director. Education and Experience: Bachelor's Degree (Level 7) in a Technical field and at least 3-5 years experience in a facilities position. At least 2 years Supervisory experience. Additional Skills: Project management experience. Proven expertise in JDE and Maximo. Experience working in a medical device industry, preferred but not essential. Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross-functional stakeholders to achieve objectives and mediating differences to achieve consensus. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control. Ensure proper handling, storage, and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests, and coordinate proper training sessions for affected personnel. #J-18808-Ljbffr
The Role Plan the procurement of the material required to support Customer Demand and New Product introduction, and develop and execute the business unit production schedule. How Will You Make An Impact? Planner Develop and schedule the Manufacturing Production Plan from the Master Production Schedule requirements with some level of complexity. Development includes the following: Manage issues preventing execution of the MPS and production plan. Issues include but are not limited to non-conforming materials or processes, material or equipment availability, completing unplanned requirements. Analyse resource availability, develop short and mid-range capacity plans with manufacturing teams, and lead teams to ensure plans are met. Generate work orders using system (e.g., JDE). Manage work order progress, including working with production and other supporting departments (e.g., quality, microbiology, engineering) to ensure production plans are met. Provide ship schedule to Supply Chain/Demand team. Creation of reports of key performance indicators and identify opportunities for potential report automation and drive these to completion. Establish and maintain gross inventory targets with a limited scope. Includes developing action plans to minimize inventory exposure and for scrapping or mitigating excess and obsolete parts based on business information, and assess inventory management. Logistics Liaise with the warehouse team for shipping and receiving of material with some level of complexity. Ensure shipment of materials by applying knowledge of import and export laws and regulations. Buyer Plan materials requirements and provide to Suppliers / Other Edwards sites to support production schedules and new product launches with some level of complexity, including: Working with the supplier to ensure materials are made to the proper specs. Leading cross-functional teams to resolve obstacles to meeting the schedule, including, but not limited to, resolving issues with non-conforming material, unclear specifications or vendor capacity constraints. Expediting purchase orders as required. Includes expediting material from the receiving dock through receiving inspection, to production stores. What Will You Need? Bachelor's Degree in related field, 4 years of related experience Required. Experience in purchasing, logistics and/or production control. Experience working in a medical device and/or regulated industry. What Else We Look For? Proven expertise in Microsoft Office Suite (Advanced Excel / Good PowerPoint & Word skills preferred). Experience MRP and ERP (e.g. JDE) preferred. Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills. Good problem-solving and critical thinking skills. Solid knowledge and understanding of Edwards policies, procedures and guidelines relevant to purchasing material, logistics, and/or production control. Solid knowledge of material requirements planning (MRP) and inventory management programs (e.g., Kanban, Min/Max). Solid knowledge of market and economic indicators, practices and procurement procedures. Strong analytic skills, with demonstrated capability in the areas of data analysis and report generation. Strict attention to detail. Ability to interact professionally with all organizational levels. Ability to manage competing priorities in a fast-paced environment. Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. In this role you will supervise a team with responsibility for ensuring that the plant operates efficiently in the day-to-day operations and in managing projects to enhance the utilization of the facilities. Key Responsibilities: Supervise facilities employees on day-to-day tasks, including walls, ceiling, floors, and exteriors reparations and maintenance; conduct performance reviews, including resolving performance issues. Ensure employees are appropriately trained to perform assigned work, including LMS System. Run and coordinate facilities projects related to building grounds. Accountable for Facilities Metrics and Reports to pursue world-class performance. Accountable for Facilities PM assigned to electricians and mechanics. Responsible for all site Facilities work orders. Provide support to the facilities engineer as requested. Assist manufacturing and engineering areas with layout changes as requested. Other duties as assigned by Manager and Director. Education and Experience: Bachelor's Degree (Level 7) in a Technical field and at least 3-5 years of experience in a facilities position. At least 2 years of Supervisory experience. Additional Skills: Project management experience. Proven expertise in JDE and Maximo. Experience working in the medical device industry, preferred but not essential. Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross-functional stakeholders to achieve objectives and mediating differences to reach consensus. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others, as well as protecting the environment and preventing pollution under their span of influence/control. Ensure proper handling, storage, and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests, and coordinate proper training sessions for affected personnel. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Production Supply Clerk ensures the transfer of materials as needed for manufacturing to ensure continuous production, in compliance with local EH&S guidelines, Edwards procedures, and other applicable regulations. Working Hours: Monday to Thursday, 5:45am - 4pm. Key Responsibilities: Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. Enter components and/or materials status in JDE to allow availability in clean room floor stock. Monitor, distribute, and maintain raw materials supply levels for product assembly process in the clean room, to ensure availability as needed, including assuring all items are stored in the appropriate place for ease of accessibility, in compliance with SOPs. Transport products between operations and place appropriate materials in each work station in the line clearance process. Prepare and distribute material kits for production. Perform inventory cycle counts and physical inventory counts, including resolving discrepancies. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. Other incidental duties: General work area housekeeping, other tasks as required by leadership. Education and Experience: H.S. Diploma or equivalent, 2 years related experience with medical device process required. Additional Skills: Good communication skills. Ability to read, comprehend, and speak English sufficiently to complete work documentation, and to convey information to colleagues. Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing. Must be able to work with minimum supervision by following SOPs and/or other instructions. Work in a Team environment, including exchanging information related to performing required tasks with colleagues, within and outside of the cleanroom. Strong computer skills, with continuously expanded knowledge of JDE and RF Smart, required. Flexibility to work varying shifts and/or overtime, as needed. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. As an Assembler at Edwards Lifesciences, you will apply skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines. Working Hours: Monday to Thursday, 5:45am-4:00pm Key Responsibilities: Use higher tools and equipment to complete assembly of medical devices precisely and in a timely fashion at each multiple work station, continuously expanding proficiency in number of operations, with exposure to multiple production lines, following work order instructions and drawings, using computers to navigate drawings, and entering parts status data. Inventory reconciliation at start of day and when transitioning to next work order. Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter data into manufacturing data systems. May perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build. Self-assessment of work, which may include visual inspection under magnification, and sequential review of colleagues' work, providing constructive team feedback, including escalating work issues and changes in equipment performance to supervisor for assessment and correction. On-time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. Other incidental duties: General work area housekeeping. Education and Experience: 2 years of previous related experience Required. H.S. Diploma or equivalent, previous medical device assembly experience Preferred. Additional Skills: Good communication skills. Able to read, comprehend and speak English, and elementary-level understanding of numerical functions. Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing. Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures. Must be able to work with minimum supervision by following detailed manufacturing instructions. Work in a team environment, primarily working with colleagues and supervisor. Ability to effectively provide and accept feedback from colleagues based on sequential work reviews. Flexibility to work overtime to ensure smooth and continuous manufacturing processes. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Inspector assesses devices in-process and upon completion, reviews accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed. Working Hours: Monday- Thursday: 5:45am-4:00pm Key Responsibilities: Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction Perform line clearance and verification of inspection Perform verification of manufacturing documents with component and device drawings Support the training of other inspectors through work demonstration and feedback May ensure smooth shift transitions by providing status de-brief of shift activities Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period Other incidental duties: General work area housekeeping Education and Experience: 2 years years experience of previous related experience, including GMP and GDP Required H.S. Diploma or equivalent Preferred Additional Skills: Good communication skills Able to read, comprehend, speak, and write English Basic computer skills, required, including working knowledge of manufacturing software Strict attention to detail Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity Full understanding of applicable inspection procedures Continuously expands proficiency in inspection techniques Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System) Must be able to work in a team environment and with minimum supervision by following detailed work instructions Ability to effectively provide and accept feedback from colleagues Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control #J-18808-Ljbffr
The Role Plan the procurement of the material required to support Customer Demand and New Product introduction, and develop and execute the business unit production schedule. How Will You Make An Impact? Planner Develop and schedule the Manufacturing Production Plan from the Master Production Schedule requirements with some level of complexity. Development includes the following: Manage issues preventing execution of the MPS and production plan. Issues include but are not limited to non-conforming materials or processes, material or equipment availability, completing unplanned requirements. Analyse resource availability, develop short and mid-range capacity plans with manufacturing teams, and lead teams to ensure plans are met. Generate work orders using system (e.g., JDE). Manage work order progress, including working with production and other supporting departments (e.g., quality, microbiology, engineering) to ensure production plans are met. Provide ship schedule to Supply Chain/Demand team. Creation of reports of key performance indicators and identify opportunities for potential report automation and drive these to completion. Establish and maintain gross inventory targets with a limited scope. Includes developing action plans to minimize inventory exposure and for scrapping or mitigating excess and obsolete parts based on business information, and assess inventory management. Logistics Liaise with the warehouse team for shipping and receiving of material with some level of complexity. Ensure shipment of materials by applying knowledge of import and export laws and regulations. Buyer Plan materials requirements and provide to Suppliers / Other Edwards sites to support production schedules and new product launches with some level of complexity, including: Working with the supplier to ensure materials are made to the proper specs. Leading cross-functional teams to resolve obstacles to meeting the schedule, including, but not limited to, resolving issues with non-conforming material, unclear specifications or vendor capacity constraints. Expediting purchase orders as required. Includes expediting material from the receiving dock through receiving inspection, to production stores. What Will You Need? Bachelor's Degree in related field, 4 years of related experience required. Experience in purchasing, logistics and/or production control. Experience working in a medical device and/or regulated industry. What Else We Look For? Proven expertise in Microsoft Office Suite (Advanced Excel / Good PowerPoint & Word skills preferred). Experience MRP and ERP (e.g. JDE) preferred. Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills. Good problem-solving and critical thinking skills. Solid knowledge and understanding of Edwards policies, procedures and guidelines relevant to purchasing material, logistics, and/or production control. Solid knowledge of material requirements planning (MRP) and inventory management programs (e.g., Kanban, Min/Max). Solid knowledge of market and economic indicators, practices and procurement procedures. Strong analytic skills, with demonstrated capability in the areas of data analysis and report generation. Strict attention to detail. Ability to interact professionally with all organizational levels. Ability to manage competing priorities in a fast-paced environment. Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. #J-18808-Ljbffr
The Role Plan the procurement of the material required to support Customer Demand and New Product introduction, and develop and execute the business unit production schedule. How Will You Make An Impact? Planner Develop and schedule the Manufacturing Production Plan from the Master Production Schedule requirements with some level of complexity. Development includes the following: Manage issues preventing execution of the MPS and production plan. Issues include but are not limited to non conforming materials or processes, material or equipment availability, completing unplanned requirements Analyse resource availability, develop short and mid range capacity plans with manufacturing teams, and lead teams to ensure plans are met Generate work orders using system (e.g., JDE) Manage work order progress, including working with production and other supporting departments(e.g., quality, microbiology, engineering) to ensure production plans are met Provide ship schedule to Supply Chain/Demand team Creation of reports of key performance indicators and identify opportunities for potential report automation and drive these to completion Establish and maintain gross inventory targets with a limited scope. Includes developing action plans to minimize inventory exposure and for scrapping or mitigating excess and obsolete parts based on business information, and assess inventory management Logistics Liaise with the warehouse team for shipping and receiving of material with some level of complexity Ensure shipment of materials by applying knowledge of import and export laws and regulations Buyer Plan materials requirements and provide to Suppliers / Other Edwards sites to support production schedules and new product launches with some level of complexity, including: Working with the supplier to ensure materials are made to the proper specs Leading cross functional teams to resolve obstacles to meeting the schedule, including, but not limited to, resolving issues with non conforming material, unclear specifications or vendor capacity constraints Expediting purchase orders as required. Includes expediting material from the receiving dock though receiving inspection, to production stores What Will You Need? Bachelor's Degree in in related field, 4 years of related experience Required Experience in purchasing, logistics and/or production control Experience working in a medical device and/or regulated industry What Else We Look For? Proven expertise in Microsoft Office Suite (Advanced Excel / Good powerpoint & word skills preferred) Experience MRP and ERP (e.g. JDE) preferred Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills Good problem-solving and critical thinking skills Solid knowledge and understanding of Edwards policies, procedures and guidelines relevant to purchasing material, logistics, and/or production control Solid knowledge of material requirements planning (MRP) and inventory management programs (e.g., Kanban,Min/Max) Solid knowledge of market and economic indicators, practices and procurement procedures Strong Analytic skills, with demonstrated capability in the areas of data analysis and report generation Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Inspector assesses devices in-process and upon completion, reviews accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed. Working Hours: Monday- Thursday: 5:45am-4:00pm Key Responsibilities: Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction Perform line clearance and verification of inspection Perform verification of manufacturing documents with component and device drawings Support the training of other inspectors through work demonstration and feedback May ensure smooth shift transitions by providing status de-brief of shift activities Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period Other incidental duties: General work area housekeeping Education and Experience: 2 years years experience of previous related experience, including GMP and GDP Required H.S. Diploma or equivalent Preferred Additional Skills: Good communication skills Able to read, comprehend, speak, and write English Basic computer skills, required, including working knowledge of manufacturing software Strict attention to detail Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity Full understanding of applicable inspection procedures Continuously expands proficiency in inspection techniques Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System) Must be able to work in a team environment and with minimum supervision by following detailed work instructions Ability to effectively provide and accept feedback from colleagues Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control #J-18808-Ljbffr
