The hours for this role are Monday-Friday 5am-1:30pmPrepares packaging and labeling for finished products, in keeping with regulatory and company guidelines.Key Responsibilities: Inspect labels and packaging to ensure quality, regulatory and SOP standards are strictly met. Perform both outer and inside packaging procedures, at a fully mastered level while working at a level of greater independence with advanced level of quality and productivity Package products, generate labels, and place labels on packaging, in strict keeping with quality, regulatory and SOP standards. Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Ensure all required components and tools are ready for the build. Perform preliminary packaging operations, including documentation review and components retrieval from warehouse Perform integrity peel-testing of inside packaging pouch Perform Silicone and/or christo-lube process Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. Perform re-labeling and packaging of warehouse returns and NCR repairs. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period Other incidental duties: General work area housekeepingEducation and Experience:H.S. Diploma or equivalent Preferred2 years experience Related experience required including GMP, clean room, medical device experience RequiredAdditional Skills: Ability to read, comprehend and speak English along with good communication skills, including giving and receiving feedback Basic computer skills required Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing 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 and supervisor Strict attendance to detail and ability to comply with standards Ability to perform packaging and labeling for finished products. Thorough understanding of manufacturing procedures. Basic computer skills required with ability to process JDE transactions 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 Candidate will be required to pass basic English skills assessmentAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $37,000 to $51,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.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 15,000 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.
