Performs sterile packaging and prepares packaging and labeling for finished products, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Load/unload valve jars into ovens per microbiology and quality standards, including ensuring samples and temperature probes are correctly placed and set in ovens
• Collect and create sterilization lot samples, prepare documentation, and transfer samples to quality labs, ensuring appropriate handling and sign-off
• Perform JDE transactions to issue packaging materials from floor stock inventory, and perform labeling, leak testing and packaging of in-process valves
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including issuing components in JDE, recording traceable information on device history records, and signing off on work orders.
• May be required to work in the Sanitization Processor role
• Other incidental duties: General work area housekeeping
Education and Experience:
H.S. Diploma or equivalent with previous GMP, clean room, medical device experience Preferred
No previous related experience Required
Additional Skills:
• Basic level of understanding of manufacturing procedures
• Basic computer skills with ability to process JDE transactions
• Ability to perform sterilize packaging and preparation of sterile components
• Ability to perform Sanitization Processor responsibilities
• 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 work with colleagues with colleagues and supervisor in a team environment
• Ability to effectively provide and accept feedback from colleagues based on sequential work reviews
• 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
• Ability to read, interpret and comprehend policies and procedures (English Speaking, preferred)
• 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
Similar Jobs
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
