Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you'll make an impact:
• Perform routine and non-routine testing services using established procedures/protocols (e.g. titration by volumetric procedures, gas (GC) and liquid (HPLC) chromatography, UV-Vis and FTIR spectrophotometric techniques, osmolality, total organic carbon (TOC) analyzers, pH and conductivity measurements, etc.) for receiving inspection, in-process solutions and final product.
• Perform data entry of routine and non-routine testing
• Collect lab samples from multiple locations
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on forms, lab electronic systems and/or device history records. Propose improvements in forms, lab electronic systems, operating procedures, etc.
• Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
• May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
• Support laboratory investigations and propose recommendations for manager view
• Prepare data summaries for laboratory reports or technical studies using existing templates as a model as well as review and approve basic laboratory data
• Execute testing or instructions associated to equipment and process validation protocols
• May train, coach, and guide lower-level technicians on new procedures, assess work techniques and provide feedback on procedures
• Other incidental duties
What you'll need (Required): Education and experience requirements
Associate's degree or equivalent in a related science field, 3 years of previous experience working in a laboratory environment Required or
Bachelor's Degree in a related science field Preferred
What else we look for (Preferred): Relevant 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
• Good knowledge of microbiological and/or sterilization requirements for medical devices, 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 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