Edwards Lifesciences Senior QA Inspector in Shannon, Ireland
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.
Key Responsibilities: • Perform visual, dimensional, and functional inspection of across all components, processes, and/or finished medical device products using all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working independently at the highest levels of productivity. Utilize all inspection equipment with proficiency, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements • Perform functional testing on all 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 supervisor for assessment and correction, and may provide recommendations to Engineering staff • Perform line clearance and verification of inspection • Perform verification of manufacturing documents with component and device drawings, which may include Geometric Dimensioning and Tolerancing methodologies • Provide coaching and training to lower level employees, evaluate and demonstrate correct approach on work of other employees; may coordinate with area leads to ensure staffing is appropriate to meet scheduling demands • May ensure smooth shift transitions by providing status de-brief of shift activities • Participate and may lead in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc. • May participate in LEAN initiatives and collaborate with R&D in the inspection of new designs • 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: 4 years years experience of previous related experience, including GMP and GDP Required H.S. Diploma or equivalent Preferred
Additional Skills: • Strong communication and interpersonal relationship skills, including ability to convey training in methodology and procedures • Strong English language skills, including reading, comprehending, speaking and writing • Good 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, including the ability to contribute to the development of procedures • Proficient in all inspection techniques for production inspection • Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality • Ability to program and contribute to the validation of automated test equipment • 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 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.