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:
- Applies scientific expertise and judgment to support chemistry testing activities and business outcomes.
- Set parameters of complex laboratory instrumentation applying chemistry knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing
- Investigate and perform corrective and preventative actions (CAPA) testing
- Create and develop validation plans for laboratory equipment and methods
- Develop lab specific protocols, reports, and methods in collaboration with team members
- Participate in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval
- Perform routine laboratory operations activities including updating documents
- Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes
- Make recommendations and validate new laboratory equipment
- May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
- Other incidental duties assigned by Leadership
What You Will Need (Required):
- Bachelor's Degree in Chemistry
- 2 year's experience in a chemistry environment
- Fluent English & Spanish
What Else We Look For (Preferred):
- Proven expertise in MS Office; Analytical Equipment System (e.g. ChemStation, Empower)
- Good written and verbal communication skills and interpersonal relationship skills
- Demonstrated problem-solving and critical thinking skills
- Good knowledge and understanding of Edwards policies and procedures relevant to chemistry
- Good knowledge and understanding of chemical principles, theories and concepts
- Good knowledge of laboratory equipment (e.g. gas Chromatography, high performance liquid chromatography, total organic carbon, fourier transform infrared spectroscopy, atomic absorption)
- Ability to manage confidential information with discretion
- 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
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
- Ability to build stable working relationships internally
- 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
Please submit your application in English