Assesses devices in-process and upon completion, reviews accompanying documentation, and conducts audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed.
• Perform visual inspection across components and devices using a wide variety of tools and equipment to ensure conformance with design specifications working at a level of greater independence with a higher level of productivity
• Perform functional testing of finished medical device products using both automated and manual valve testing equipment
• Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards
• Authorize the set up of line start up, verify compliance with established line set up procedures for packaging and labeling
• Work with cross-functional teams to investigate nonconformance issues
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties (e.g. occasional photo copying or deliveries)
Education and Experience:
H.S. Diploma or equivalent 2 years experience Previous related experience and internship experience Required
Other: in technical degree in fields such as electronics, metrology, computer operations Preferred
• Good skills required in:_x000D_
o Computer utilization
• Able to read and comprehend English, required; speaking and writing English, preferred
• Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity
• Full understanding of applicable inspection procedures and/or drawings
• Continuously expands proficiency in inspection techniques
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Must be able to work in a team environment and with minimum supervision by following detailed work instructions
• 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.