Edwards Lifesciences Quality Assurance Supervisor in Shannon, Ireland
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Assess components and devices upon receipt to ensure regulatory and company guidelines have been met, and that the components and devices meet operational standards as designed.
• Understanding of expert visual, dimensional, and functional inspection of components and devices using a wide variety of all applicable instruments and equipment such as magnifying lamp, microscope, vision inspection system, callipers, etc. to ensure conformance with design specifications, working independently at the highest levels of productivity
• Understanding of verification of receiving documents with component and device drawings to ensure requirements are met, including drawings that use Geometric Dimensioning and Tolerancing methodologies
• Review, follow and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE.
• Control inventory and schedule replenishment to ensure appropriate storage conditions and movement, as well as ensuring correct labelling of product status.
• Provide coaching and training to lower level employees, confirm understanding and increased competency ,evaluate and demonstrate correct approach on work of other employees, and may assign work to lower level employees ensuring balanced work along lines and across shifts.
• Identify and escalate work issues
• Manage daily work assignments of Inspectors including overseeing employee job performance such as attendance, quality and productivity.
•Plan, assigns and adjusts work priorities to meet daily, weekly, monthly planning requirements
• Supports Quality reporting metrics; provides data for tracking metrics. Assists in development of root-cause analysis and ensures corrective/ preventive actions are implemented to address non-conformances.
•Initiation and support of continual improvement solutions for new and enhanced methods for inspection, testing, and evaluation of data throughout Edwards processes.
•Work with relevant Engineering Teams to establish inspection plans, frequencies and test methods for incoming material/parts.
• Other incidental duties: General work area housekeeping, attend training for new processes and procedures
Education and Experience:
•BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
•At least three years Quality Supervisor experience in an inspection/lab environment or related role within the medical device industry including direct supervision of 5-10 employees
• Demonstrated ability to lead teams, coach others, and transfer knowledge
• Ability to use all applicable instruments and equipment, hand eye coordination, and high manual dexterity
• Full understanding of applicable inspection procedures, including the ability develop procedures
• Proficient in all inspection techniques for receiving inspection
• Ability to guide other workers/colleagues in understanding operations and quality standards
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
• Ability to program and contribute to the validation of automated test equipment
• Ability to effectively provide and accept feedback from colleagues on independent data verification and follow up with colleagues to ensure understanding
• Ability to provide performance feedback, confirm understanding, and have a positive impact on competency and output of other inspectors
• Strong English language skills, including reading, comprehending, speaking and writing, and strong communication skills
• Proficient computer skills, including MS Office Suite and/or manufacturing system (e.g., JDE)
• Strict attention to detail
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.