Edwards Lifesciences Senior Laboratory Technician, Quality in Irvine, California
Provide testing services in a laboratory environment
Key Responsibilities: • Perform routine and non-routine testing services using established procedures/protocols (e.g D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc) • Collect environmental lab samples from multiple cleanrooms • Perform data entry of routine and non-routine testing • Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records • Assist in testing validation/revalidation activities for critical systems and equipment under close supervision • Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations • May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule • Initiate and support laboratory investigations and propose recommendations for manager view • Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data • Execute equipment and process validation protocols • Assess and qualify new equipment • May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures • Other incidental duties
Education and Experience: Associate's Degree or equivalent in in related science field, 3 years experience working in a laboratory Required
Additional Skills: • Good written and verbal communication, interpersonal, and relationship building skills • Able to read, comprehend, write and speak English • Good computer skills, including usage of MS Office; Analytical Equipment System (e.g ChemStation, Empower) preferred • Substantial knowledge of laboratory processes • Substantial knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations • Substantial knowledge in mathematics, e.g., decimals and percentages • Ability to write technical documents • Good knowledge with ISO microbiological sterilization documents if applicable • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing • Strict attention to detail • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment • Must be able to work in a team environment • Ability to provide feedback in a professional, direct, and tactful manner • Ability to represent the organization to outside contacts, i.e., vendors • Adhere to all EHS rules and requirements 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.
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.