Job Description

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 will make an Impact:

• Provide testing services in a laboratory environment

• Perform routine and non-routine testing services by using established procedures/protocols (e.g., manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc.)

• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records

• Perform investigations on CAPA forms e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval

• Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes

• Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis

• Create and develop validation plans for laboratory equipment and methods

• Lead laboratory investigations and propose recommendations and solutions for manager approval

• Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations

• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures

• Other incidental duties

What you will need (Required):

• Associate's Degree or equivalent in Chemistry

• 2 years experience working in a laboratory

• Fluent in English & Spanish

What else we look for (Preferred):

• Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation, Empower)

• Full knowledge of laboratory processes

• Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations

• Full knowledge in mathematics, e.g., decimals and percentages

• Ability to write technical documents

• Strong 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 an inter-departmental team environment, as well as with colleagues from other departments

• 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