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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
Other: 2 Years years experience previous related experience in GMP, clean room, medical device experience Required or
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
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
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
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