Performs sterile packaging and prepares packaging and labeling for finished products, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Load and unload valves into/from equipment, operate equipment, perform labeling & packaging in compliance with established work instructions and adherence with SOPs.
• Perform line clearance, including verifying all valve serial numbers are as listed on the work order being executed, issuing of components in JDE, recording of traceable information on device history records, and signing off on work orders.
• Perform tools cleaning/sanitization and packing of components/parts prior to sterilization process.
• Monitor inventory levels and prevent out of stock situations
• Other incidental duties: General work area housekeeping, deliver micro samples
Education and Experience:
• 2 years previous related experience in GMP, clean room, medical device experience required
• Secondary Education preferred
Additional Skills:
• Good understanding of manufacturing procedures
• Basic computer skills required; working knowledge of JDE and RFSMART
• 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 perform product packaging
• Ability to perform Sanitization Processor responsibilities
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
• Able to read, comprehend and speak English, and good communication skills, required
• 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
• Strict attendance to detail and ability to comply with standards
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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
