Perform final documentation review for sterilized products, conduct inspections and provide administrative support in other quality-related activities.
Key Responsibilities:
• Review records for completeness and route to the next process step (e.g., Device History Records (DHR), ECRs)
• Prepare and upload paper records into electronic document system
• May process records and requests for offsite record storage and retrieval
• May train on some operations to lower level staff
• May accompany vendors during site visits (e.g, shredding, offsite storage)
• Other incidental duties (e.g. occasional photo copying or deliveries)
Education and Experience:
H.S. Diploma or equivalent 2 Years years experience previous related experience Required
Additional Skills:
• Good computer skills including working knowledge of Microsoft Office Suite, PDM (Product Document Management) system, and Ignite preferred
• Good communication and interpersonal relationship skills
• Able to read, write, comprehend, and speak English
• General knowledge and understanding of Edwards policies and procedures
• Good written and verbal communications skills
• Good problem-solving skills
• Attention to detail
• Must be able to work in a team environment under general supervision and with instructions for routine work
• Detailed instructions given for new activities or special assignments to ensure desired outcomes
• 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.
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.