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
About Edwards Lifesciences
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.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
EEO is the Law click here for more information regarding Equal Employment Opportunity
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice